bundle-drug-stability-pq-ex1-prod
type: Bundle
node role: treeRoot
id:
  v: bundle-drug-stability-pq-ex1-prod
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq
type:
  v: collection

urn:…
type: DiagnosticReport
id:
  v: diagnosticreport-analysis-drug-pq-stability-prod
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: DiagnosticReport Resource DiagnosticReport "diagnosticreport-analysis-drug-pq-stability-prod" Profile: DiagnosticReport - Analysis Drug PQ Triggered by: See on this page: PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54 Extension - Statistical Model PQ: information about statistical model utilized to interpret stability study results () Extension - Container Orientation PQ: Horizontal (Container Orientation Codes#horizontal "horizontal") identifier: https://eudract.europa.eu/example/identifier/ABC1234 status: final code: Stability Study Report - 18 months (Pharmaceutical Report Type Codes#Stability Study Report - 18 months) effective: 2020-12 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 result: See on this page: Observation/6fabbf78-9678-8030-485f-b149956308d5 See on this page: Observation/74535cc6-5232-5ab5-81cf-167a480795e5 See on this page: Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6 See on this page: Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c See on this page: Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73 See on this page: Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a See on this page: Observation/72e0640b-094b-909e-5268-3dee92af4bbd conclusion: The samples have been assessed and the conclusion is that the shelf life can be 18 months.
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-statistical-model-pq
  value: CodeableConcept
    text:
      v: information about statistical model utilized to interpret stability study results
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-container-orientation-pq
  value: CodeableConcept
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/container-orientation
      code:
        v: horizontal
      display:
        v: horizontal
    text:
      v: Horizontal
identifier:
  system:
    v: https://eudract.europa.eu/example/identifier
  value:
    v: ABC1234
status:
  v: final
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type
    code:
      v: Stability Study Report - 18 months
    display:
      v: Stability Study Report - 18 months
effective:
  v: 2020-12
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-time-point-description-pq
    value: CodeableConcept
      text:
        v: Refrigerated delayed testing
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/6fabbf78-9678-8030-485f-b149956308d5
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/74535cc6-5232-5ab5-81cf-167a480795e5
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/72e0640b-094b-909e-5268-3dee92af4bbd
conclusion:
  v: The samples have been assessed and the conclusion is that the shelf life can be 18 months.

urn:…
type: PlanDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: PlanDefinition Resource PlanDefinition "c96cb248-1408-79fc-1f47-b17a6b2e4b54" Profile: PlanDefinition - Drug PQ url: http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54 title: Stability Monitoring Program type: Stability Study Protocol (Pharmaceutical Plan Type Codes#1244588) status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Narrative description of Stability Study action title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg action title: Long-Term description: 25°C/60% RH action action action action action action action action title: Accelerated description: 40°C/75% RH action action action action action action action
url:
  v: http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54
title:
  v: Stability Monitoring Program
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type
    code:
      v: 1244588
    display:
      v: Stability Study Protocol
status:
  v: active
subject: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
description:
  v: Narrative description of Stability Study
action:
  title:
    v: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg
  action:
    title:
      v: Long-Term
    description:
      v: 25°C/60% RH
    action:
      title:
        v: Initial
      timing: Timing
    action:
      title:
        v: 3
      timing: Timing
    action:
      title:
        v: 6
      timing: Timing
    action:
      title:
        v: 9
      timing: Timing
    action:
      title:
        v: 12
      timing: Timing
    action:
      title:
        v: 18
      timing: Timing
    action:
      title:
        v: 24
      timing: Timing
  action:
    title:
      v: Accelerated
    description:
      v: 40°C/75% RH
    action:
      title:
        v: Initial
      timing: Timing
    action:
      title:
        v: 3
      timing: Timing
    action:
      title:
        v: 6
      timing: Timing
    action:
      title:
        v: 9
      timing: Timing
    action:
      title:
        v: 12
      timing: Timing
    action:
      title:
        v: 18
      timing: Timing
    action:
      title:
        v: 24
      timing: Timing

urn:…
type: SpecimenDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" Profile: SpecimenDefinition - Drug PQ url: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 status: active typeTested preference: preferred Handlings - Instruction * 25°C/60% RH
url:
  v: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
status:
  v: active
type tested:
  preference:
    v: preferred
  handling:
    instruction:
      v: 25°C/60% RH

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "610ca25c-6126-6117-8d4d-9458ccc33ce2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
url:
  v: http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2
title:
  v: Long-term - 25°C/60% RH - X
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "d99c1b63-2d32-4887-8157-525cc8ae4732" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
url:
  v: http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732
title:
  v: Long-term - 25°C/60% RH - X
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "38704856-0acf-95f0-000f-a933b6862fa0" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
url:
  v: http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0
title:
  v: Long-term - 25°C/60% RH - X
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 title: Long-term - 25°C/60% RH - XYZ status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851, http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409
url:
  v: http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
title:
  v: Long-term - 25°C/60% RH - XYZ
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
  link: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409
  link: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "f19a68b0-4ba1-7288-635e-12783035935b" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
url:
  v: http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b
title:
  v: Long-term - 25°C/60% RH - XY
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
  link: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "ce2df6ab-5087-435c-35cb-a84572e756a2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
url:
  v: http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2
title:
  v: Long-term - 25°C/60% RH - XY
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
  link: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "cf2df6ab-5087-435c-35cb-a84572e756a2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2 title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
url:
  v: http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2
title:
  v: Long-term - 25°C/60% RH - XY
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
  link: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
  link: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "d1d252cf-9d58-43a0-85f6-56a7f7f92774" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774 title: X status: active code: Battery of tests 'X' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
url:
  v: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
title:
  v: X
status:
  v: active
code:
  text:
    v: Battery of tests 'X' at 25°C/60% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "1178fc31-0cfd-8c60-0b5b-9ae2850c6774" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 title: Description status: active code: Description (Example Local Codes - Drug#DESC) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
title:
  v: Description
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DESC
    display:
      v: Description
  text:
    v: Description
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: An orange film-coated tablet, debossed with 175 on one side

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "2c5683d6-6e94-825b-056a-129a04c95e2f" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f title: Degradation Products by HPLC (% w/w) status: active code: Degradation Products (Example Local Codes - Drug#DGP) qualifiedValue appliesTo: Impurity 1 () range: ?-0.8 qualifiedValue appliesTo: Impurity 2 () range: ?-0.4 qualifiedValue appliesTo: Impurity 3 () range: ?-0.4 qualifiedValue appliesTo: Any Unspecified Degradation Impurity () range: ?-0.2 qualifiedValue appliesTo: Total Degradation Impurities () range: ?-2.3 Components - Code * Impurity (Example Local Codes - Drug#IMP)
url:
  v: http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
title:
  v: Degradation Products by HPLC (% w/w)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DGP
    display:
      v: Degradation Products
qualified value:
  applies to:
    text:
      v: Impurity 1
  range:
    high:
      value:
        v: 0.8
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
qualified value:
  applies to:
    text:
      v: Impurity 2
  range:
    high:
      value:
        v: 0.4
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
qualified value:
  applies to:
    text:
      v: Impurity 3
  range:
    high:
      value:
        v: 0.4
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
qualified value:
  applies to:
    text:
      v: Any Unspecified Degradation Impurity
  range:
    high:
      value:
        v: 0.2
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
qualified value:
  applies to:
    text:
      v: Total Degradation Impurities
  range:
    high:
      value:
        v: 2.3
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: IMP
      display:
        v: Impurity

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "186eb33e-a01d-4252-166c-b5ba5e8a697c" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c title: Water Content (% w/w) (Mean) status: active code: Water Content (Example Local Codes - Drug#WaterContent) QualifiedValues - Range * ?-0.2
url:
  v: http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
title:
  v: Water Content (% w/w) (Mean)
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
  text:
    v: Water Content
qualified value:
  range:
    high:
      value:
        v: 0.2
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "b62b9524-53af-84ae-1071-2867a2169851" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851 title: Y status: active code: Battery of tests 'Y' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
url:
  v: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
title:
  v: Y
status:
  v: active
code:
  text:
    v: Battery of tests 'Y' at 25°C/60% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e title: Microbiological status: active code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
title:
  v: Microbiological
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
  text:
    v: Microbiological Quality
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Complies with PhEur

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "363384c8-0d79-5ff0-5538-4933f99d6409" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409 title: Z status: active code: Battery of tests 'Z' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
url:
  v: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409
title:
  v: Z
status:
  v: active
code:
  text:
    v: Battery of tests 'Z' at 25°C/60% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef781c18-8e86-7859-209b-469ee9ad42d8" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 title: Uniformity of dosage status: active code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
title:
  v: Uniformity of dosage
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: uniformity of dosage units (by weight)
  text:
    v: uniformity of dosage units (by weight)
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Complies

urn:…
type: SpecimenDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "e95109ac-5ef9-1723-3506-2ef2f2e33d87" url: http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 status: active typeTested preference: preferred Handlings - Instruction * 40°C/75% RH
url:
  v: http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87
status:
  v: active
type tested:
  preference:
    v: preferred
  handling:
    instruction:
      v: 40°C/75% RH

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "096e3f32-798e-6792-76ad-4ea783521c50" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50 title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
url:
  v: http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50
title:
  v: Accelerated - 40°C/70% RH - X
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
  link: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "77f86b13-8193-3df7-8362-ab5e79ba541d" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
url:
  v: http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d
title:
  v: Accelerated - 40°C/70% RH - X
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
  link: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b

urn:…
type: ActivityDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ActivityDefinition Resource ActivityDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b title: Accelerated - 40°C/70% RH - XYZ status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b, http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2, http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0
url:
  v: http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
title:
  v: Accelerated - 40°C/70% RH - XYZ
status:
  v: active
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
  link: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2
  link: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2
observation requirement:
  v: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0
  link: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b title: X status: active code: Battery of tests 'X' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
url:
  v: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
title:
  v: X
status:
  v: active
code:
  text:
    v: Battery of tests 'X' at 40°C/75% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "58cb0710-0ee6-1b7a-2a64-61a01df95ac2" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2 title: Y status: active code: Battery of tests 'Y' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
url:
  v: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2
title:
  v: Y
status:
  v: active
code:
  text:
    v: Battery of tests 'Y' at 40°C/75% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

urn:…
type: ObservationDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "9bc183ee-6017-789b-8a6f-6a5c339f9ae0" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0 title: Z status: active code: Battery of tests 'Z' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
url:
  v: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0
title:
  v: Z
status:
  v: active
code:
  text:
    v: Battery of tests 'Z' at 25°C/60% RH
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87
has member:
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

urn:…
type: Specimen
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955bd" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-01 processing description: No storage processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-01
processing:
  description:
    v: No storage
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Specimen
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955be" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-02 processing description: No storage processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-02
processing:
  description:
    v: No storage
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Specimen
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928b-5def2a9955be" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-03 processing description: No storage processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-03
processing:
  description:
    v: No storage
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Observation
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "6fabbf78-9678-8030-485f-b149956308d5" Profile: Observation - Test Result Drug PQ Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928a-5def2a9955bd hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04…
contained: Observation
  id:
    v: LongTerm25C-initial-1-Description
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
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  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: observation-test-result-lt25c-i1-degradation-imp1
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
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    v: final
  code:
    coding:
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        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
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    value:
      v: 0.101
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 1
contained: Observation
  id:
    v: LongTerm25C-initial-1-Degradation-imp2
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.201
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 2
contained: Observation
  id:
    v: LongTerm25C-initial-1-Degradation-imp3
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
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  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.201
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 3
contained: Observation
  id:
    v: LongTerm25C-initial-1-Degradation-impUnspecified
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
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  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.101
    comparator:
      v: <
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Any Unspecified Degradation Impurity

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "74535cc6-5232-5ab5-81cf-167a480795e5" Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928a-5def2a9955be hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 …
contained: Observation
  id:
    v: LongTerm25C-initial-2-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-initial-2-Degradation
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.1
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
contained: Observation
  id:
    v: LongTerm25C-initial-2-Microbiological
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: Microbiological Quality
      display:
        v: Microbiological Quality
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value:
    v: Complies
contained: Observation
  id:
    v: LongTerm25C-initial-2-Uniformity
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: uniformity-dosage
      display:
        v: Uniformity of dosage units (by weight)
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
status:
  v: final
code:
  text:
    v: Test Components - Long-term 25C etc - Initial (XYZ)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/Specimen/b664977d-799d-a1ce-928a-5def2a9955be
has member:
  reference:
    v: #LongTerm25C-initial-2-Description
has member:
  reference:
    v: #LongTerm25C-initial-2-Degradation
has member:
  reference:
    v: #LongTerm25C-initial-2-Microbiological
has member:
  reference:
    v: #LongTerm25C-initial-2-Uniformity

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928b-5def2a9955be hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+00…
contained: Observation
  id:
    v: LongTerm25C-initial-3-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-initial-3-Degradation
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.1
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
contained: Observation
  id:
    v: LongTerm25C-initial-3-Microbiological
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: Microbiological Quality
      display:
        v: Microbiological Quality
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-initial-3-Uniformity
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: uniformity-dosage
      display:
        v: Uniformity of dosage units (by weight)
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90
status:
  v: final
code:
  text:
    v: Test Components - Long-term 25C etc - Initial (XYZ)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/Specimen/b664977d-799d-a1ce-928b-5def2a9955be
has member:
  reference:
    v: #LongTerm25C-initial-3-Description
has member:
  reference:
    v: #LongTerm25C-initial-3-Degradation
has member:
  reference:
    v: #LongTerm25C-initial-3-Microbiological
has member:
  reference:
    v: #LongTerm25C-initial-3-Uniformity

urn:…
type: Specimen
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c78" Collections - Collected[x] * 2020-12-01 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-01
processing:
  description:
    v: Store for 18 months
  time: Period
    extension:
      url:
        v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
      value: Duration
    start:
      v: 2020-12
    end:
      v: 2022-06
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Specimen
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c88" Collections - Collected[x] * 2020-12-02 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-02
processing:
  description:
    v: Store for 18 months
  time: Period
    extension:
      url:
        v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
      value: Duration
    start:
      v: 2020-12
    end:
      v: 2022-06
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Specimen
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c89" Collections - Collected[x] * 2020-12-03 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
collection:
  collected:
    v: 2020-12-03
processing:
  description:
    v: Store for 18 months
  time: Period
    extension:
      url:
        v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
      value: Duration
    start:
      v: 2020-12
    end:
      v: 2022-06
processing:
  description:
    v: 25°C/60% RH

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "e803ad6d-0cb3-87dd-6af1-4b88c654a47c" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c78 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Pro…
contained: Observation
  id:
    v: LongTerm25C-18m-1-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-18m-1-Degradation-imp1
  meta:
    profile:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
      link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.118
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 1
contained: Observation
  id:
    v: LongTerm25C-18m-1-Degradation-imp2
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.218
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 2
contained: Observation
  id:
    v: LongTerm25C-18m-1-Degradation-imp3
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.218
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 3
contained: Observation
  id:
    v: LongTerm25C-18m-1-Degradation-impUnspecified
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.118
    comparator:
      v: <
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Any Unspecified Degradation Impurity
contained: Observation
  id:
    v: LongTerm25C-18m-1-Degradation-impTotal
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  value: Quantity

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "3519f84a-2889-90a0-a6b7-ff2f1be66a73" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c88 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply Generated Narrative: Observation #LongTerm25C-18m-2-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-2-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00…
contained: Observation
  id:
    v: LongTerm25C-18m-2-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-18m-2-Microbiological
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: Microbiological Quality
      display:
        v: Microbiological Quality
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value:
    v: Does not comply
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2
status:
  v: final
code:
  text:
    v: Test Components - Long-term 25C etc - 18 months (XY)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/8306cfc5-158f-1a53-a683-048b226060d9
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/Specimen/18826818-10c4-972c-618e-01694ff06c88
has member:
  reference:
    v: #LongTerm25C-18m-2-Description
has member:
  reference:
    v: #LongTerm25C-18m-2-Microbiological

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "2ef362f1-0b65-3578-7f06-fbd74a24694a" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c89 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply Generated Narrative: Observation #LongTerm25C-18m-3-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-3-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00…
contained: Observation
  id:
    v: LongTerm25C-18m-3-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: LongTerm25C-18m-3-Microbiological
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: Microbiological Quality
      display:
        v: Microbiological Quality
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value:
    v: Does not comply
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2
status:
  v: final
code:
  text:
    v: Test Components - Long-term 25C etc - 18 months (XY)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
specimen:
  link: http://hl7.org/fhir/uv/pharm-quality/Specimen/18826818-10c4-972c-618e-01694ff06c89
has member:
  reference:
    v: #LongTerm25C-18m-3-Description
has member:
  reference:
    v: #LongTerm25C-18m-3-Microbiological

urn:…
type: Specimen
text:
  status:
    v: generated
  div: Generated Narrative: Specimen Resource Specimen "8a7771db-5cc0-33f8-966a-b2f792bf5785" Collections - Collected[x] * 2020-12-01 processing description: Store for 3 months time: 2020-12 --> 2021-03 processing description: 40°C/75% RH
collection:
  collected:
    v: 2020-12-01
processing:
  description:
    v: Store for 3 months
  time: Period
    extension:
      url:
        v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-storage-duration-pq
      value: Duration
    start:
      v: 2020-12
    end:
      v: 2021-03
processing:
  description:
    v: 40°C/75% RH

urn:…
type: Observation
text:
  status:
    v: extensions
  div: Generated Narrative: Observation Resource Observation "72e0640b-094b-909e-5268-3dee92af4bbd" Triggered by: See on this page: ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50 status: final code: Test Components - Accelerated 40C etc - 3 Months (X) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.143 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.243 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Pro…
contained: Observation
  id:
    v: Accelerated40C-3-1-Description
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DESC
      display:
        v: Description
    text:
      v: Description
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: CodeableConcept
    text:
      v: Complies
contained: Observation
  id:
    v: Accelerated40C-3-1-Degradation-imp1
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.143
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 1
contained: Observation
  id:
    v: Accelerated40C-3-1-Degradation-imp2
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.243
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 2
contained: Observation
  id:
    v: Accelerated40C-3-1-Degradation-imp3
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.201
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Impurity 3
contained: Observation
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.101
    comparator:
      v: <
    unit:
      v: % w/w
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  component:
    value: CodeableConcept
      text:
        v: Any Unspecified Degradation Impurity
contained: Observation
  id:
    v: Accelerated40C-3-1-Degradation-impTotal
  instantiates: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
  status:
    v: final
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: DGP
      display:
        v: Degradation Products
    text:
      v: Degradation Products
  subject:
    link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
  effective:
    v: 2023-01-01T12:00:00Z
  performer:
    link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
  value: Quantity
    value:
      v: 0.801
    unit:
      v: % w/w

urn:…
type: Medication
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Medication Resource Medication "7ef62d57-7cc6-9211-66d6-abc7e096093c" Profile: Medication - Batch Information Drug PQ code: () Batches - Extension LotNumber * , , , , , 33445
code:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
batch:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
    extension:
      url:
        v: manufacturingDate
      value:
        v: 2020-06
    extension:
      url:
        v: batchQuantity
      value: Quantity
    extension:
      url:
        v: batchUtilization
      value: CodeableConcept
    extension:
      url:
        v: assignedManufacturer
      value: Reference
        link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
    extension:
      url:
        v: container
      extension:
        value: CodeableConcept
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
    value:
      v: 2019-09-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Substance/fc078762-81c5-5656-9744-13c7ad1e595b
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq
    value:
      v: 2020-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
    value: Quantity
      value:
        v: 4.8
      unit:
        v: kg
  lot number:
    v: 33445

urn:…
type: Medication
text:
  status:
    v: generated
  div: Generated Narrative: Medication Resource Medication "8306cfc5-158f-1a53-a683-048b226060d9" code: () Batches - Extension LotNumber * , , , , , 33446
code:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
batch:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
    extension:
      url:
        v: manufacturingDate
      value:
        v: 2020-06
    extension:
      url:
        v: batchQuantity
      value: Quantity
    extension:
      url:
        v: batchUtilization
      value: CodeableConcept
    extension:
      url:
        v: assignedManufacturer
      value: Reference
        link: http://hl7.org/fhir/uv/pharm-quality/Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd
    extension:
      url:
        v: container
      extension:
        value: CodeableConcept
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
    value:
      v: 2019-09-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Substance/cb31d747-2338-88d5-342c-8e9c097e4dad
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq
    value:
      v: 2020-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
    value: Quantity
      value:
        v: 4.8
      unit:
        v: kg
  lot number:
    v: 33446

urn:…
type: Medication
text:
  status:
    v: generated
  div: Generated Narrative: Medication Resource Medication "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b" code: () Batches - Extension LotNumber * , , , , , 33447
code:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
batch:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
    extension:
      url:
        v: manufacturingDate
      value:
        v: 2020-06
    extension:
      url:
        v: batchQuantity
      value: Quantity
    extension:
      url:
        v: batchUtilization
      value: CodeableConcept
    extension:
      url:
        v: assignedManufacturer
      value: Reference
        link: http://hl7.org/fhir/uv/pharm-quality/Organization/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd
    extension:
      url:
        v: container
      extension:
        value: CodeableConcept
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
    value:
      v: 2019-09-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Substance/1551f97b-6f6d-825e-1fb3-44b0b090808c
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq
    value:
      v: 2020-08
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
    value: Quantity
      value:
        v: 4.8
      unit:
        v: kg
  lot number:
    v: 33447

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" identifier: urn:oid:2.16.840.1.113883.4.82/3010027650 active: true type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture) name: AAA Pharmaceutical, Inc. Contacts - Address * 681 Main Street Lumberton New Jersey 08048 USA
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 3010027650
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
    code:
      v: drug-product-manufacture
    display:
      v: Drug Product Manufacture
name:
  v: AAA Pharmaceutical, Inc.
contact:
  address:
    line:
      v: 681 Main Street
    city:
      v: Lumberton
    state:
      v: New Jersey
    postal code:
      v: 08048
    country:
      v: USA

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc" identifier: urn:oid:2.16.840.1.113883.4.82/3008816891 active: true type: Packaging (Pharmaceutical Organization Type Codes#packaging) name: MySite
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 3008816891
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
    code:
      v: packaging
    display:
      v: Packaging
name:
  v: MySite

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability) name: Advanced Analytical Testing Laboratories Inc. Contacts - Address * 30 Silverline Drive North Brunswick New Jersey 08902 USA
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 3007270600
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
    code:
      v: analytical-testing-stability
    display:
      v: Analytical Testing - Stability
name:
  v: Advanced Analytical Testing Laboratories Inc.
contact:
  address:
    line:
      v: 30 Silverline Drive
    city:
      v: North Brunswick
    state:
      v: New Jersey
    postal code:
      v: 08902
    country:
      v: USA

urn:…
type: MedicinalProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" Profile: MedicinalProductDefinition - Drug Product PQ description: Textual description of the product combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000) route: Oral use (standardterms.edqm.eu#20053000) name productName: Stelbat Tablets, 20mg type: Proprietary (Product Name Type - example#Proprietary) Parts - Part Type * 20mg Strength part (Product Name Part Type#StrengthPart)
description:
  v: Textual description of the product
combined pharmaceutical dose form:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 10225000
    display:
      v: Gastro-resistant tablet
route:
  coding:
    system:
      v: http://standardterms.edqm.eu
    code:
      v: 20053000
    display:
      v: Oral use
name:
  product name:
    v: Stelbat Tablets, 20mg
  type:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example
      code:
        v: Proprietary
      display:
        v: Proprietary
  part:
    part:
      v: 20mg

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" Profile: Ingredient - Drug Pq status: active for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 role: Active (Ingredient Role#100000072072) substance Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
status:
  v: active
for:
  link: http://hl7.org/fhir/uv/pharm-quality/MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role:
  coding:
    system:
      v: http://hl7.org/fhir/ingredient-role
    code:
      v: 100000072072
    display:
      v: Active
substance:
  code:
    reference:
      link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" Profile: SubstanceDefinition - Component Substance Drug PQ manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Names - Name * Stelbatolol
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
name:
  name:
    v: Stelbatolol

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" Profile: Organization - Drug PQ identifier: urn:oid:2.16.840.1.113883.4.82/3003040516 active: true type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture) name: AAA Molybdenum Products, Inc. Contacts - Address * 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
identifier:
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 3003040516
active:
  v: true
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type
    code:
      v: drug-substance-manufacture
    display:
      v: Drug Substance Manufacture
name:
  v: AAA Molybdenum Products, Inc.
contact:
  address:
    line:
      v: 7233 W 116th Pl
    line:
      v: Ste C
    city:
      v: Broomfield
    state:
      v: Colorado
    postal code:
      v: 80020
    country:
      v: USA

urn:…
type: Substance
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 5
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq
  value:
    v: 2019-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
  value:
    v: 2022-09-08
extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq
  value: Quantity
    value:
      v: 4.8
    unit:
      v: kg
identifier:
  value:
    v: CAT1
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

urn:…
type: Substance
text:
  status:
    v: extensions
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extension:
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    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2019-09-07
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 5
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c
extension:
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  value:
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extension:
  url:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq
  value:
    v: 2022-09-08
extension:
  url:
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    value:
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    unit:
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identifier:
  value:
    v: CAT2
instance:
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code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390

urn:…
type: Substance
text:
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extension:
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  extension:
    url:
      v: manufacturingDate
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  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
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      unit:
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  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
  extension:
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      v: assignedManufacturer
    value: Reference
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extension:
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  value:
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extension:
  url:
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  value:
    v: 2022-09-08
extension:
  url:
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    value:
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    unit:
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identifier:
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instance:
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code:
  reference:
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v: Delayed Start Code

v: Delayed Start Code

bounds: Range
  low:
    value:
      v: 0
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
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  high:
    value:
      v: 0
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
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frequency:
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v: XYZ

bounds: Range
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    unit:
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    system:
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    code:
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  high:
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    unit:
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    system:
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    code:
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frequency:
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v: X

bounds: Range
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    system:
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    code:
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  high:
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    unit:
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    system:
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    code:
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frequency:
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v: X

bounds: Range
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    unit:
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    system:
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    code:
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    unit:
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    system:
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    code:
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frequency:
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v: X

bounds: Range
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    unit:
      v: months
    system:
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    code:
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  high:
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    unit:
      v: months
    system:
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    code:
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frequency:
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v: XY

bounds: Range
  low:
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    unit:
      v: months
    system:
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    code:
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  high:
    value:
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    unit:
      v: months
    system:
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    code:
      v: mo
frequency:
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v: XY

bounds: Range
  low:
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      v: 24
    unit:
      v: months
    system:
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    code:
      v: mo
  high:
    value:
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    unit:
      v: months
    system:
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    code:
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frequency:
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v: XY

bounds: Range
  low:
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    unit:
      v: months
    system:
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    code:
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    unit:
      v: months
    system:
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    code:
      v: mo
frequency:
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v: XYZ

bounds: Range
  low:
    value:
      v: 3
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 3
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: X

bounds: Range
  low:
    value:
      v: 6
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 6
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: X

bounds: Range
  low:
    value:
      v: 9
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 9
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: -

bounds: Range
  low:
    value:
      v: 12
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 12
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: -

bounds: Range
  low:
    value:
      v: 18
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 18
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: -

bounds: Range
  low:
    value:
      v: 24
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
  high:
    value:
      v: 24
    unit:
      v: months
    system:
      v: http://unitsofmeasure.org
    code:
      v: mo
frequency:
  v: 1

v: -

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

Observation
id:
  v: LongTerm25C-initial-1-Degradation-impTotal
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DGP
    display:
      v: Degradation Products
  text:
    v: Degradation Products
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: Quantity
  value:
    v: 0.801
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: IMP
      display:
        v: Impurity
  value: CodeableConcept
    text:
      v: Total Degradation Impurities

Observation
id:
  v: LongTerm25C-initial-1-Water
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: Quantity
  value:
    v: 0.1501
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

Observation
id:
  v: LongTerm25C-initial-1-Microbiological
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: CodeableConcept
  text:
    v: Complies

Observation
id:
  v: LongTerm25C-initial-1-Uniformity
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: Uniformity of dosage units (by weight)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: CodeableConcept
  text:
    v: Complies

v: final

text:
  v: Test Components - Long-term 25C etc - Initial (XYZ)

v: 2023-01-01T12:00:00Z

reference:
  v: #LongTerm25C-initial-1-Description

reference:
  v: #observation-test-result-lt25c-i1-degradation-imp1

reference:
  v: #LongTerm25C-initial-1-Degradation-imp2

reference:
  v: #LongTerm25C-initial-1-Degradation-imp3

reference:
  v: #LongTerm25C-initial-1-Degradation-impUnspecified

reference:
  v: #LongTerm25C-initial-1-Degradation-impTotal

reference:
  v: #LongTerm25C-initial-1-Water

reference:
  v: #LongTerm25C-initial-1-Microbiological

reference:
  v: #LongTerm25C-initial-1-Uniformity

v: 18

v: month

v: 18

v: month

v: 18

v: month

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

Quantity
value:
  v: 0.818
unit:
  v: % w/w
system:
  v: http://unitsofmeasure.org
code:
  v: %

code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IMP
    display:
      v: Impurity
value: CodeableConcept
  text:
    v: Total Degradation Impurities

Observation
id:
  v: LongTerm25C-18m-1-Water
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
subject:
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effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: Quantity
  value:
    v: 0.1518
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

Observation
id:
  v: LongTerm25C-18m-1-Microbiological
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value:
  v: Complies

Observation
id:
  v: LongTerm25C-18m-1-Uniformity
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: Uniformity of dosage units (by weight)
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: CodeableConcept
  text:
    v: Complies

v: final

text:
  v: Test Components - Long-term 25C etc - 18 months (XY)

v: 2023-01-01T12:00:00Z

reference:
  v: #LongTerm25C-18m-1-Description

reference:
  v: #LongTerm25C-18m-1-Degradation-imp1

reference:
  v: #LongTerm25C-18m-1-Degradation-imp2

reference:
  v: #LongTerm25C-18m-1-Degradation-imp3

reference:
  v: #LongTerm25C-18m-1-Degradation-impUnspecified

reference:
  v: #LongTerm25C-18m-1-Degradation-impTotal

reference:
  v: #LongTerm25C-18m-1-Water

reference:
  v: #LongTerm25C-18m-1-Microbiological

reference:
  v: #LongTerm25C-18m-1-Uniformity

v: 18

v: month

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

v: IMP

v: Impurity

v: %

code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IMP
    display:
      v: Impurity
value: CodeableConcept
  text:
    v: Total Degradation Impurities

Observation
id:
  v: Accelerated40C-3-1-Water
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: WaterContent
    display:
      v: Water Content
subject:
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effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: Quantity
  value:
    v: 0.1501
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

Observation
id:
  v: Accelerated40C-3-1-Microbiological
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Microbiological Quality
    display:
      v: Microbiological Quality
subject:
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effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: CodeableConcept
  text:
    v: Complies

Observation
id:
  v: Accelerated40C-3-1-Uniformity
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: uniformity-dosage
    display:
      v: Uniformity of dosage units (by weight)
subject:
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effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9
value: CodeableConcept
  text:
    v: Complies

v: final

text:
  v: Test Components - Accelerated 40C etc - 3 Months (X)

v: 2023-01-01T12:00:00Z

reference:
  v: #Accelerated40C-3-1-Description

reference:
  v: #Accelerated40C-3-1-Degradation-imp1

reference:
  v: #Accelerated40C-3-1-Degradation-imp2

reference:
  v: #Accelerated40C-3-1-Degradation-imp3

reference:
  v: #Accelerated40C-3-1-Water

reference:
  v: #Accelerated40C-3-1-Microbiological

reference:
  v: #Accelerated40C-3-1-Uniformity

v: 100100

v: tablets

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
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display:
  v: Commercial

v: Production

v: type

CodeableConcept
text:
  v: 100 cc HDPE Bottle 2 g desiccant

v: closureSystemDescription

v: Standard closure

v: 100050

v: tablets

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C133990
display:
  v: Commercial

v: Production

v: type

CodeableConcept
text:
  v: 100 cc HDPE Bottle 2 g desiccant

v: 100125

v: tablets

system:
  v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code:
  v: C133990
display:
  v: Commercial

v: Production

v: type

CodeableConcept
text:
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v: StrengthPart

v: Strength part

v: C133991

v: Development

v: C133991

v: Development

v: C133991

v: Development