bundle-batch-analysis-pq-ex2-sub
type: Bundle
node role: treeRoot
id:
  v: bundle-batch-analysis-pq-ex2-sub
meta:
  profile:
    v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq
    link: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq
type:
  v: collection

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 "2038e4c7-22b8-4c56-2d28-6c077648763f" Profile: PlanDefinition - Drug PQ url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f title: S.4.4 BATCH ANALYSIS type: Specification Protocol (Pharmaceutical Plan Type Codes#1244577) status: active subject: See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130 description: Narrative description of analysis action title: Batch Specification for Drug Substance code: Overall set of actions () Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f * Test () http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 * Test () http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 * Test () http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 * Test () http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b * Test () http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 * Test () http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 * Test () http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 * Test () http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
url:
  v: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
title:
  v: S.4.4 BATCH ANALYSIS
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type
    code:
      v: 1244577
    display:
      v: Specification Protocol
status:
  v: active
subject: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
description:
  v: Narrative description of analysis
action:
  title:
    v: Batch Specification for Drug Substance
  code:
    text:
      v: Overall set of actions
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
      link: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
      link: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
      link: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
      link: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
      link: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
      link: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
      link: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
      link: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
  action:
    code:
      text:
        v: Test
    definition:
      v: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
      link: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "13033a89-927a-10e0-503e-5f901bdca30f" url: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f title: Description status: active code: Description (Example Local Codes - Drug#DESC) method: Visual inspection () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
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
method:
  text:
    v: Visual inspection
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: A white to brown powder

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "8395ae1d-5064-0ab7-a297-6b20285b2230" url: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) method: Identification by IR spectroscopy Identification by HPLC () QualifiedValues - Extension *
url:
  v: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
title:
  v: Identification
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: Identification
method:
  text:
    v: Identification by IR spectroscopy Identification by HPLC
qualified value:
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq
    value:
      v: Conforms with reference

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "2117208e-4185-9091-1f86-cce37b121838" url: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by LC () QualifiedValues - Range * 98-102 % w/w
url:
  v: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
title:
  v: Assay
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay
method:
  text:
    v: Assay by LC
qualified value:
  range:
    low:
      value:
        v: 98
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    high:
      value:
        v: 102
      unit:
        v: % w/w
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8" url: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 title: Drug Substance Related Organic impurities status: active code: Drug Substance Related Organic impurities (Example Local Codes - Drug#DGP-s) method: Organic impurities by LC () qualifiedValue appliesTo: Impurity 1 () range: ?-0.5 qualifiedValue appliesTo: Impurity 2 () range: ?-0.5 qualifiedValue appliesTo: Impurity 3 () range: ?-0.5 qualifiedValue appliesTo: Any individual unspecified impurity () range: ?-0.10 qualifiedValue appliesTo: Total impurities () range: ?-2.0 Components - Code * Impurity (Example Local Codes - Drug#IMP)
url:
  v: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
title:
  v: Drug Substance Related Organic impurities
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: DGP-s
    display:
      v: Drug Substance Related Organic impurities
method:
  text:
    v: Organic impurities by LC
qualified value:
  applies to:
    text:
      v: Impurity 1
  range:
    high:
      value:
        v: 0.5
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 2
  range:
    high:
      value:
        v: 0.5
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Impurity 3
  range:
    high:
      value:
        v: 0.5
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Any individual unspecified impurity
  range:
    high:
      value:
        v: 0.10
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Total impurities
  range:
    high:
      value:
        v: 2.0
      unit:
        v: % w/w
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
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "0634020c-8729-99fc-7637-89799d7c445b" url: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b title: Mutagenic impurities status: active code: Mutagenic impurities (Example Local Codes - Drug#MUT) method: Impurity 5 content by LC-MS () QualifiedValues - AppliesTo Range * Impurity - Mutagenic () ?-50 Components - Code * Impurity (Example Local Codes - Drug#IMP)
url:
  v: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
title:
  v: Mutagenic impurities
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: MUT
    display:
      v: Mutagenic impurities
method:
  text:
    v: Impurity 5 content by LC-MS
qualified value:
  applies to:
    text:
      v: Impurity - Mutagenic
  range:
    high:
      value:
        v: 50
      unit:
        v: ppm
      system:
        v: http://unitsofmeasure.org
      code:
        v: [ppm]
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
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "4e67725b-20c8-158e-9d53-1810bfa58d87" url: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 title: Enantiomeric purity status: active code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) method: Enantiomeric purity by LC () QualifiedValues - Range * 99.6-? %
url:
  v: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
title:
  v: Enantiomeric purity
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: enantiomeric-purity
    display:
      v: Enantiomeric purity
  text:
    v: Enantiomeric purity
method:
  text:
    v: Enantiomeric purity by LC
qualified value:
  range:
    low:
      value:
        v: 99.6
      unit:
        v: %
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "2daba8ca-211f-4f4b-4028-16c30fe22ee8" url: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 title: Residual solvents status: active code: Residual solvents (Example Local Codes - Drug#SOL) method: Residual solvents by headspace GC () qualifiedValue appliesTo: Solvent 1 () range: ?-0.1 qualifiedValue appliesTo: Solvent 2 () range: ?-2.0 Components - Code * Solvent (Example Local Codes - Drug#SOLV)
url:
  v: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
title:
  v: Residual solvents
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
method:
  text:
    v: Residual solvents by headspace GC
qualified value:
  applies to:
    text:
      v: Solvent 1
  range:
    high:
      value:
        v: 0.1
      unit:
        v: % w/w
qualified value:
  applies to:
    text:
      v: Solvent 2
  range:
    high:
      value:
        v: 2.0
      unit:
        v: % w/w
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: SOLV
      display:
        v: Solvent

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "17b322fe-53ea-6c1f-521b-3b148ac05eb4" url: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP Karl Fischer titration () QualifiedValues - Range * ?-1.0
url:
  v: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
title:
  v: Water Content
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
method:
  text:
    v: USP Karl Fischer titration
qualified value:
  range:
    high:
      value:
        v: 1.0
      unit:
        v: % w/w

urn:…
type: ObservationDefinition
text:
  status:
    v: generated
  div: Generated Narrative: ObservationDefinition Resource ObservationDefinition "11fcfe6b-7498-132b-2def-efae51b302d4" url: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 title: Particle size distribution status: active code: Particle size distribution (Example Local Codes - Drug#PART) method: Laser diffraction () qualifiedValue appliesTo: D(v,0.9) () range: ?-319 qualifiedValue appliesTo: D(v,0.5) () range: ?-145 qualifiedValue appliesTo: D(v,0.1) () range: ?-20 Components - Code * Particle size (Example Local Codes - Drug#PARTS)
url:
  v: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
title:
  v: Particle size distribution
  extension:
    url:
      v: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq
    value:
      v: Particle Size Distribution was included in the release specification throughout clinical development, and no longer forms a part of the commercial release specification; See Section S.4.5 Justification of Specification for data and rationale.
status:
  v: active
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
method:
  text:
    v: Laser diffraction
qualified value:
  applies to:
    text:
      v: D(v,0.9)
  range:
    high:
      value:
        v: 319
      unit:
        v: µm
      system:
        v: http://unitsofmeasure.org
      code:
        v: um
qualified value:
  applies to:
    text:
      v: D(v,0.5)
  range:
    high:
      value:
        v: 145
      unit:
        v: µm
      system:
        v: http://unitsofmeasure.org
      code:
        v: um
qualified value:
  applies to:
    text:
      v: D(v,0.1)
  range:
    high:
      value:
        v: 20
      unit:
        v: µm
      system:
        v: http://unitsofmeasure.org
      code:
        v: um
component:
  code:
    coding:
      system:
        v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
      code:
        v: PARTS
      display:
        v: Particle size

urn:…
type: Substance
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1" Medication Manufacturing Batch url batchQuantity value: 120 kg url manufacturingDate value: 2020-01 url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Manufacturing Process PQ: See on this page: PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: true Codes - Reference * See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 120
      unit:
        v: kg
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2020-01
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
      text:
        v: Production
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/3d399cbc-244e-9b5f-838b-b7daa0489330
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-manufacturing-process-pq
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975
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/8dae93e0-048d-35a4-71ea-7c603184a130

urn:…
type: Substance
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4" Medication Manufacturing Batch url manufacturingDate value: 2020-02 url batchQuantity value: 120 kg url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT2 instance: true Codes - Reference * See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2020-02
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 120
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
      text:
        v: Production
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/3d399cbc-244e-9b5f-838b-b7daa0489330
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: CAT2
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130

urn:…
type: Substance
text:
  status:
    v: extensions
  div: Generated Narrative: Substance Resource Substance "ef17cff1-6586-a4a4-9168-2602140548d7" Medication Manufacturing Batch url manufacturingDate value: 2020-03 url batchQuantity value: 120 kg url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT3 instance: true Codes - Reference * See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch
  extension:
    url:
      v: manufacturingDate
    value:
      v: 2020-03
  extension:
    url:
      v: batchQuantity
    value: Quantity
      value:
        v: 120
      unit:
        v: kg
  extension:
    url:
      v: batchUtilization
    value: CodeableConcept
      text:
        v: Production
  extension:
    url:
      v: assignedManufacturer
    value: Reference
      link: http://hl7.org/fhir/uv/pharm-quality/Organization/3d399cbc-244e-9b5f-838b-b7daa0489330
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: CAT3
instance:
  v: true
code:
  reference:
    link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130

urn:…
type: PlanDefinition
text:
  status:
    v: generated
  div: Generated Narrative: PlanDefinition Resource PlanDefinition "b30a1024-37db-a1bc-05e5-cc4596d92975" url: http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975 title: Process 1.1 type: Manufacturing Process (Pharmaceutical Plan Type Codes#1244566) status: active subject: See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
url:
  v: http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975
title:
  v: Process 1.1
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type
    code:
      v: 1244566
    display:
      v: Manufacturing Process
status:
  v: active
subject: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130

urn:…
type: SubstanceDefinition
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "8dae93e0-048d-35a4-71ea-7c603184a130" manufacturer: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Names - Name * Stelbatolol
manufacturer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/3d399cbc-244e-9b5f-838b-b7daa0489330
name:
  name:
    v: Stelbatolol

urn:…
type: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "3d399cbc-244e-9b5f-838b-b7daa0489330" 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: Organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release) name: Testing Lab
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-release
    display:
      v: Analytical Testing - Release
name:
  v: Testing Lab

urn:…
type: DiagnosticReport
id:
  v: batchAnalysisReport
text:
  status:
    v: extensions
  div: Generated Narrative: DiagnosticReport Resource DiagnosticReport "batchAnalysisReport" Triggered by: See on this page: PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f status: final code: Batch Analysis Report (Pharmaceutical Report Type Codes#Batch Analysis Report) effective: 2020-12 result: See on this page: Observation/81f552f9-8458-3cf4-8379-eea5417a9de2 See on this page: Observation/50bf6f69-a3f5-678b-469b-c5df5cca4c86 See on this page: Observation/145fd3b7-3678-867f-4298-a6c781b86de3 See on this page: Observation/55c89944-60d1-4eea-a2c3-6c53e3622bc5 See on this page: Observation/adb51ab6-00a9-1078-69e5-d32c025a857c See on this page: Observation/916a0ae2-9c43-72f0-a22a-c5f8ce902125 See on this page: Observation/6deb4306-1193-24ae-a565-f73225652bdd See on this page: Observation/f6aabd2f-5902-57e7-6126-eccd9158a5b5 See on this page: Observation/32f598e4-a0e0-98dc-41dd-0f8397f953ad See on this page: Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d See on this page: Observation/d3e572b7-14fd-744b-4123-58741d75571e See on this page: Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8 See on this page: Observation/da92c71f-a12a-1980-11a3-80e3d1852244 See on this page: Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6 See on this page: Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487 See on this page: Observation/732237a9-4b3b-27cc-99ca-6b913e622a29 See on this page: Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec See on this page: Observation/7fc395b1-59e4-78be-0512-cf92133c0fac See on this page: Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572 See on this page: Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2 See on this page: Observation/0244eafe-3126-909b-7d8d-4253f45f525c See on this page: Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c See on this page: Observation/84f015ac-9572-324f-8013-0b999cc95bbd See on this page: Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e See on this page: Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d See on this page: Observation…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
  value: Reference
    link: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
status:
  v: final
code:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/pharmaceutical-report-type
    code:
      v: Batch Analysis Report
    display:
      v: Batch Analysis Report
effective:
  v: 2020-12
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/81f552f9-8458-3cf4-8379-eea5417a9de2
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/50bf6f69-a3f5-678b-469b-c5df5cca4c86
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/145fd3b7-3678-867f-4298-a6c781b86de3
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/55c89944-60d1-4eea-a2c3-6c53e3622bc5
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/adb51ab6-00a9-1078-69e5-d32c025a857c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/916a0ae2-9c43-72f0-a22a-c5f8ce902125
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/6deb4306-1193-24ae-a565-f73225652bdd
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/f6aabd2f-5902-57e7-6126-eccd9158a5b5
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/32f598e4-a0e0-98dc-41dd-0f8397f953ad
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/d3e572b7-14fd-744b-4123-58741d75571e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/da92c71f-a12a-1980-11a3-80e3d1852244
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/31bfeff4-4a7d-3be5-878e-fb674d3d5487
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/732237a9-4b3b-27cc-99ca-6b913e622a29
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/7fc395b1-59e4-78be-0512-cf92133c0fac
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/0244eafe-3126-909b-7d8d-4253f45f525c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/84f015ac-9572-324f-8013-0b999cc95bbd
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/d3e572b7-14fd-744b-4123-58741d75571e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/da92c71f-a12a-1980-11a3-80e3d1852244
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/31bfeff4-4a7d-3be5-878e-fb674d3d5487
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/732237a9-4b3b-27cc-99ca-6b913e622a29
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/7fc395b1-59e4-78be-0512-cf92133c0fac
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/0244eafe-3126-909b-7d8d-4253f45f525c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/84f015ac-9572-324f-8013-0b999cc95bbd
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/ff26533d-88a8-7f18-a275-42dc1373a388
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/c99666d2-7962-9a71-58f6-7b2e5aa662f5
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/c18e21d3-7113-4d08-4ff3-0c9718596f64
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/66fdac46-2a6b-a66f-891b-8dcf67cc46c7
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/8306cfc5-158f-1a53-a683-048b226060d9
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/fc49ad55-07d1-997d-6695-bbff44746e75
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/f8160692-a7a8-3fa6-9f35-e7df35f51ac0
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/a531aee9-4c21-06af-352c-a3615b5d957e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/ba8a182e-8571-6cbd-047b-612735d599d2
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/0b5b94cc-7a1a-4ada-66c7-954ceb528d67
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/6afaacee-11a6-58b2-47df-5f79722c66ac
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/c2644a86-1684-286e-00e2-dcaf907a8970
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/cb5f6872-6eeb-727a-7c33-f2c438581a1c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/7faaf980-7c10-7b9a-9572-1bacd485824e
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/e4d2118a-8562-9eb1-2c14-4e145d2a95fc
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/ec078717-9512-4db4-77c6-2c7e29d213a6
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/05cfb495-2580-561a-688d-ce6ea24c8962
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/d2a60ae5-96b4-3d13-38da-729c652347a3
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/c3f51325-2f5f-194c-919b-2219ee1f5c45
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/e9d89693-11b1-13ed-5cde-606fc1b8372c
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/2659b000-96e2-1b8b-129b-0c00e1074b0f
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/10b47328-36fa-343d-5699-5b32b30a6d33
result:
  link: http://hl7.org/fhir/uv/pharm-quality/Observation/e6780766-317a-382f-92d2-79825f506cc5
conclusion:
  v: The samples have been assessed and the conclusion is...

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "81f552f9-8458-3cf4-8379-eea5417a9de2" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
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/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Pass

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "50bf6f69-a3f5-678b-469b-c5df5cca4c86" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
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/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Pass

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "145fd3b7-3678-867f-4298-a6c781b86de3" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
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/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Pass

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "55c89944-60d1-4eea-a2c3-6c53e3622bc5" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: Identification
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Conforms

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "adb51ab6-00a9-1078-69e5-d32c025a857c" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not conform ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: Identification
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Does not conform

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "916a0ae2-9c43-72f0-a22a-c5f8ce902125" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: IDT
    display:
      v: Identification
  text:
    v: Identification
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: CodeableConcept
  text:
    v: Conforms

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "6deb4306-1193-24ae-a565-f73225652bdd" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 94 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 94
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "f6aabd2f-5902-57e7-6126-eccd9158a5b5" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 95 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 95
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "32f598e4-a0e0-98dc-41dd-0f8397f953ad" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 96 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: ASSAY
    display:
      v: Assay
  text:
    v: Assay
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 96
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "02d9e6be-833c-1c6d-a64a-baa3935c959d" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.5
  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: Impurity 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "d3e572b7-14fd-744b-4123-58741d75571e" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.4
  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: Impurity 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "fe6ca484-a755-9a0b-a074-b6ee0a907ff8" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.2
  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: Impurity 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "da92c71f-a12a-1980-11a3-80e3d1852244" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.5
  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: Impurity 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.4
  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: Impurity 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "31bfeff4-4a7d-3be5-878e-fb674d3d5487" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.2
  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: Impurity 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "732237a9-4b3b-27cc-99ca-6b913e622a29" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Impurity 3

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "52afbeb4-4958-a275-a0ca-d70b2b5240ec" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Impurity 3

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "7fc395b1-59e4-78be-0512-cf92133c0fac" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Impurity 3

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any individual unspecified impurity ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Any individual unspecified impurity

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "97b16ff8-8e0f-915a-9d65-7fab108f40c2" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any individual unspecified impurity ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Any individual unspecified impurity

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "0244eafe-3126-909b-7d8d-4253f45f525c" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any individual unspecified impurity ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: Any individual unspecified impurity

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "10b80cbd-45d3-9be1-63b9-29f04b47376c" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.02
  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 impurities

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "84f015ac-9572-324f-8013-0b999cc95bbd" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.02
  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 impurities

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "987daeaa-4c2a-72b7-780f-4a9403163a3e" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: Impurities
    display:
      v: Impurities
  text:
    v: Impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.02
  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 impurities

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "ff26533d-88a8-7f18-a275-42dc1373a388" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic impurities (Example Local Codes - Drug#MUT) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 20 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity - Mutagenic ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: MUT
    display:
      v: Mutagenic impurities
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 20
  unit:
    v: ppm
  system:
    v: http://unitsofmeasure.org
  code:
    v: [ppm]
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: Impurity - Mutagenic

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "c99666d2-7962-9a71-58f6-7b2e5aa662f5" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities") subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 22 % (Details: UCUM code % = '%')
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: MUT
    display:
      v: Mutagenic impurities
  text:
    v: Mutagenic
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 22
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "c18e21d3-7113-4d08-4ff3-0c9718596f64" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities") subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 18 % (Details: UCUM code % = '%')
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: MUT
    display:
      v: Mutagenic impurities
  text:
    v: Mutagenic
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 18
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "66fdac46-2a6b-a66f-891b-8dcf67cc46c7" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: enantiomeric-purity
    display:
      v: Enantiomeric purity
  text:
    v: Enantiomeric purity
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 91.5
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "8306cfc5-158f-1a53-a683-048b226060d9" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: enantiomeric-purity
    display:
      v: Enantiomeric purity
  text:
    v: Enantiomeric purity
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 91.5
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "fc49ad55-07d1-997d-6695-bbff44746e75" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: enantiomeric-purity
    display:
      v: Enantiomeric purity
  text:
    v: Enantiomeric purity
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 91.5
  unit:
    v: %
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
note:
  text:
    v: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "f8160692-a7a8-3fa6-9f35-e7df35f51ac0" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "a531aee9-4c21-06af-352c-a3615b5d957e" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 1

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "ba8a182e-8571-6cbd-047b-612735d599d2" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 1.4
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "0b5b94cc-7a1a-4ada-66c7-954ceb528d67" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 1.5
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "6afaacee-11a6-58b2-47df-5f79722c66ac" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: SOL
    display:
      v: Residual solvents
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 1.2
  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: SOLV
      display:
        v: Solvent
  value: CodeableConcept
    text:
      v: Solvent 2

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "c2644a86-1684-286e-00e2-dcaf907a8970" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
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
  text:
    v: Water Content
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.8
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "cb5f6872-6eeb-727a-7c33-f2c438581a1c" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
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
  text:
    v: Water Content
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.8
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "7faaf980-7c10-7b9a-9572-1bacd485824e" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
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
  text:
    v: Water Content
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.8
  unit:
    v: % w/w
  system:
    v: http://unitsofmeasure.org
  code:
    v: %

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "e4d2118a-8562-9eb1-2c14-4e145d2a95fc" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) D(v,0.9) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.5
  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: D(v,0.9)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "ec078717-9512-4db4-77c6-2c7e29d213a6" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) D(v,0.9) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.4
  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: D(v,0.9)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "05cfb495-2580-561a-688d-ce6ea24c8962" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.9) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.2
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.9)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "d2a60ae5-96b4-3d13-38da-729c652347a3" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.5
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.5)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "c3f51325-2f5f-194c-919b-2219ee1f5c45" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.4
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.5)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "e9d89693-11b1-13ed-5cde-606fc1b8372c" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.2
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.5)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "2659b000-96e2-1b8b-129b-0c00e1074b0f" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.1)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "10b47328-36fa-343d-5699-5b32b30a6d33" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.1)

urn:…
type: Observation
text:
  status:
    v: generated
  div: Generated Narrative: Observation Resource Observation "e6780766-317a-382f-92d2-79825f506cc5" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()
instantiates: Reference
  link: http://hl7.org/fhir/uv/pharm-quality/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status:
  v: final
code:
  coding:
    system:
      v: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example
    code:
      v: PART
    display:
      v: Particle size distribution
subject:
  link: http://hl7.org/fhir/uv/pharm-quality/Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective:
  v: 2023-01-01T12:00:00Z
performer:
  link: http://hl7.org/fhir/uv/pharm-quality/Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Quantity
  value:
    v: 0.1
  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: SIZE
      display:
        v: Particle Size
  value: CodeableConcept
    text:
      v: D(v,0.1)

v: Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data

v: C133990

v: Commercial

v: C133990

v: Commercial

v: C133990

v: Commercial