Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle – Stability, product

Bundle bundle-drug-stability-pq-ex1-prod of type collection


Entry 1 - fullUrl = urn:uuid:6f4a3311-92c5-2b4a-533e-76341e414c63

Resource DiagnosticReport:

Stability Study Report - 18 months

When For2020-12
Identifier: https://eudract.europa.eu/example/identifier/ABC1234

Report Details

CodeValueWhen For
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - 18 months (XY)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - 18 months (XY)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - 18 months (XY)2023-01-01 12:00:00+0000
Test Components - Accelerated 40C etc - 3 Months (X)2023-01-01 12:00:00+0000

The samples have been assessed and the conclusion is that the shelf life can be 18 months.


Entry 2 - fullUrl = urn:uuid:c96cb248-1408-79fc-1f47-b17a6b2e4b54

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "c96cb248-1408-79fc-1f47-b17a6b2e4b54"

Profile: PlanDefinition - Drug PQ

url: http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54

title: Stability Monitoring Program

type: Stability Study Protocol (planType#1244588)

status: ACTIVE

subject: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

description: Narrative description of Stability Study

action

title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg

action

action


Entry 3 - fullUrl = urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition

Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"

Profile: SpecimenDefinition - Drug PQ

url: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2

status: ACTIVE

typeTested

preference: PREFERRED

Handlings

-Instruction
*25°C/60% RH


Entry 4 - fullUrl = urn:uuid:610ca25c-6126-6117-8d4d-9458ccc33ce2

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "610ca25c-6126-6117-8d4d-9458ccc33ce2"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2

title: Long-term - 25°C/60% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774


Entry 5 - fullUrl = urn:uuid:d99c1b63-2d32-4887-8157-525cc8ae4732

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "d99c1b63-2d32-4887-8157-525cc8ae4732"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732

title: Long-term - 25°C/60% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774


Entry 6 - fullUrl = urn:uuid:38704856-0acf-95f0-000f-a933b6862fa0

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "38704856-0acf-95f0-000f-a933b6862fa0"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0

title: Long-term - 25°C/60% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774


Entry 7 - fullUrl = urn:uuid:4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90

title: Long-term - 25°C/60% RH - XYZ

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851, http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409


Entry 8 - fullUrl = urn:uuid:f19a68b0-4ba1-7288-635e-12783035935b

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "f19a68b0-4ba1-7288-635e-12783035935b"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b

title: Long-term - 25°C/60% RH - XY

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851


Entry 9 - fullUrl = urn:uuid:ce2df6ab-5087-435c-35cb-a84572e756a2

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "ce2df6ab-5087-435c-35cb-a84572e756a2"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2

title: Long-term - 25°C/60% RH - XY

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851


Entry 10 - fullUrl = urn:uuid:cf2df6ab-5087-435c-35cb-a84572e756a2

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "cf2df6ab-5087-435c-35cb-a84572e756a2"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2

title: Long-term - 25°C/60% RH - XY

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851


Entry 11 - fullUrl = urn:uuid:d1d252cf-9d58-43a0-85f6-56a7f7f92774

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "d1d252cf-9d58-43a0-85f6-56a7f7f92774"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774

title: X

status: ACTIVE

code: Battery of tests 'X' at 25°C/60% RH ()

specimen: See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)

hasMember:


Entry 12 - fullUrl = urn:uuid:1178fc31-0cfd-8c60-0b5b-9ae2850c6774

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "1178fc31-0cfd-8c60-0b5b-9ae2850c6774"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

title: Description

status: ACTIVE

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

QualifiedValues

-Extension
*


Entry 13 - fullUrl = urn:uuid:2c5683d6-6e94-825b-056a-129a04c95e2f

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "2c5683d6-6e94-825b-056a-129a04c95e2f"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

title: Degradation Products by HPLC (% w/w)

status: ACTIVE

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

qualifiedValue

appliesTo: Impurity 1 ()

range: ?-0.8

qualifiedValue

appliesTo: Impurity 2 ()

range: ?-0.4

qualifiedValue

appliesTo: Impurity 3 ()

range: ?-0.4

qualifiedValue

appliesTo: Any Unspecified Degradation Impurity ()

range: ?-0.2

qualifiedValue

appliesTo: Total Degradation Impurities ()

range: ?-2.3

Components

-Code
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)


Entry 14 - fullUrl = urn:uuid:186eb33e-a01d-4252-166c-b5ba5e8a697c

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "186eb33e-a01d-4252-166c-b5ba5e8a697c"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

title: Water Content (% w/w) (Mean)

status: ACTIVE

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

QualifiedValues

-Range
*?-0.2


Entry 15 - fullUrl = urn:uuid:b62b9524-53af-84ae-1071-2867a2169851

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "b62b9524-53af-84ae-1071-2867a2169851"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851

title: Y

status: ACTIVE

code: Battery of tests 'Y' at 25°C/60% RH ()

specimen: See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)

hasMember: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)


Entry 16 - fullUrl = urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

title: Microbiological

status: ACTIVE

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

QualifiedValues

-Extension
*


Entry 17 - fullUrl = urn:uuid:363384c8-0d79-5ff0-5538-4933f99d6409

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "363384c8-0d79-5ff0-5538-4933f99d6409"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409

title: Z

status: ACTIVE

code: Battery of tests 'Z' at 25°C/60% RH ()

specimen: See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)

hasMember: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)


Entry 18 - fullUrl = urn:uuid:ef781c18-8e86-7859-209b-469ee9ad42d8

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "ef781c18-8e86-7859-209b-469ee9ad42d8"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

title: Uniformity of dosage

status: ACTIVE

code: uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

QualifiedValues

-Extension
*


Entry 19 - fullUrl = urn:uuid:e95109ac-5ef9-1723-3506-2ef2f2e33d87

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition

Resource SpecimenDefinition "e95109ac-5ef9-1723-3506-2ef2f2e33d87"

url: http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87

status: ACTIVE

typeTested

preference: PREFERRED

Handlings

-Instruction
*40°C/75% RH


Entry 20 - fullUrl = urn:uuid:096e3f32-798e-6792-76ad-4ea783521c50

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "096e3f32-798e-6792-76ad-4ea783521c50"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50

title: Accelerated - 40°C/70% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b


Entry 21 - fullUrl = urn:uuid:77f86b13-8193-3df7-8362-ab5e79ba541d

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "77f86b13-8193-3df7-8362-ab5e79ba541d"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d

title: Accelerated - 40°C/70% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b


Entry 22 - fullUrl = urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b"

Profile: ActivityDefinition - Test Drug PQ

url: http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

title: Accelerated - 40°C/70% RH - XYZ

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b, http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2, http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0


Entry 23 - fullUrl = urn:uuid:792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b

title: X

status: ACTIVE

code: Battery of tests 'X' at 40°C/75% RH ()

specimen: See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)

hasMember:


Entry 24 - fullUrl = urn:uuid:58cb0710-0ee6-1b7a-2a64-61a01df95ac2

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "58cb0710-0ee6-1b7a-2a64-61a01df95ac2"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2

title: Y

status: ACTIVE

code: Battery of tests 'Y' at 40°C/75% RH ()

specimen: See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)

hasMember: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)


Entry 25 - fullUrl = urn:uuid:9bc183ee-6017-789b-8a6f-6a5c339f9ae0

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "9bc183ee-6017-789b-8a6f-6a5c339f9ae0"

Profile: ObservationDefinition - Test Method PQ

url: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0

title: Z

status: ACTIVE

code: Battery of tests 'Z' at 25°C/60% RH ()

specimen: See above (SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87)

hasMember: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)


Entry 26 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955bd"

Profile: Specimen - Drug PQ

Collections

-Collected[x]
*2020-12-01

processing

description: No storage

processing

description: 25°C/60% RH


Entry 27 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955be

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955be"

Profile: Specimen - Drug PQ

Collections

-Collected[x]
*2020-12-02

processing

description: No storage

processing

description: 25°C/60% RH


Entry 28 - fullUrl = urn:uuid:b664977d-799d-a1ce-928b-5def2a9955be

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "b664977d-799d-a1ce-928b-5def2a9955be"

Profile: Specimen - Drug PQ

Collections

-Collected[x]
*2020-12-03

processing

description: No storage

processing

description: 25°C/60% RH


Entry 29 - fullUrl = urn:uuid:6fabbf78-9678-8030-485f-b149956308d5

Resource Observation:

Generated Narrative: Observation

Resource Observation "6fabbf78-9678-8030-485f-b149956308d5"

Profile: Observation - Test Result Drug PQ

Triggered by: See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)

status: FINAL

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

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955bd)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: <0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.801 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

instantiates: See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.1501 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-1-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #observation-test-result-lt25c-i1-degradation-imp1

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp2

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp3

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impUnspecified

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: <0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impTotal

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.801 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

Generated Narrative: Observation #LongTerm25C-initial-1-Water

instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.1501 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm25C-initial-1-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-1-Uniformity

instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Entry 30 - fullUrl = urn:uuid:74535cc6-5232-5ab5-81cf-167a480795e5

Resource Observation:

Generated Narrative: Observation

Resource Observation "74535cc6-5232-5ab5-81cf-167a480795e5"

Triggered by: See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)

status: FINAL

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

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/b664977d-799d-a1ce-928a-5def2a9955be)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.1 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies

instantiates: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-2-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-2-Degradation

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.1 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm25C-initial-2-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies


Generated Narrative: Observation #LongTerm25C-initial-2-Uniformity

instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Entry 31 - fullUrl = urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6

Resource Observation:

Generated Narrative: Observation

Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6"

Triggered by: See above (ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90)

status: FINAL

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

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/b664977d-799d-a1ce-928b-5def2a9955be)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.1 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-3-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-3-Degradation

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.1 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm25C-initial-3-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-initial-3-Uniformity

instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Entry 32 - fullUrl = urn:uuid:18826818-10c4-972c-618e-01694ff06c78

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "18826818-10c4-972c-618e-01694ff06c78"

Collections

-Collected[x]
*2020-12-01

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 25°C/60% RH


Entry 33 - fullUrl = urn:uuid:18826818-10c4-972c-618e-01694ff06c88

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "18826818-10c4-972c-618e-01694ff06c88"

Collections

-Collected[x]
*2020-12-02

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 25°C/60% RH


Entry 34 - fullUrl = urn:uuid:18826818-10c4-972c-618e-01694ff06c89

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "18826818-10c4-972c-618e-01694ff06c89"

Collections

-Collected[x]
*2020-12-03

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 25°C/60% RH


Entry 35 - fullUrl = urn:uuid:e803ad6d-0cb3-87dd-6af1-4b88c654a47c

Resource Observation:

Generated Narrative: Observation

Resource Observation "e803ad6d-0cb3-87dd-6af1-4b88c654a47c"

Triggered by: See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)

status: FINAL

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

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/18826818-10c4-972c-618e-01694ff06c78)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: <0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

instantiates: See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.1518 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies

instantiates: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()


Generated Narrative: Observation #LongTerm25C-18m-1-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp1

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp2

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp3

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impUnspecified

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: <0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impTotal

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

Generated Narrative: Observation #LongTerm25C-18m-1-Water

instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.1518 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm25C-18m-1-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies


Generated Narrative: Observation #LongTerm25C-18m-1-Uniformity

instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Entry 36 - fullUrl = urn:uuid:3519f84a-2889-90a0-a6b7-ff2f1be66a73

Resource Observation:

Generated Narrative: Observation

Resource Observation "3519f84a-2889-90a0-a6b7-ff2f1be66a73"

Triggered by: See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)

status: FINAL

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

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/18826818-10c4-972c-618e-01694ff06c88)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/8306cfc5-158f-1a53-a683-048b226060d9)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Does not comply


Generated Narrative: Observation #LongTerm25C-18m-2-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-18m-2-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Does not comply


Entry 37 - fullUrl = urn:uuid:2ef362f1-0b65-3578-7f06-fbd74a24694a

Resource Observation:

Generated Narrative: Observation

Resource Observation "2ef362f1-0b65-3578-7f06-fbd74a24694a"

Triggered by: See above (ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2)

status: FINAL

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

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/18826818-10c4-972c-618e-01694ff06c89)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Does not comply


Generated Narrative: Observation #LongTerm25C-18m-3-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #LongTerm25C-18m-3-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Does not comply


Entry 38 - fullUrl = urn:uuid:8a7771db-5cc0-33f8-966a-b2f792bf5785

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "8a7771db-5cc0-33f8-966a-b2f792bf5785"

Collections

-Collected[x]
*2020-12-01

processing

description: Store for 3 months

time: 2020-12 --> 2021-03

processing

description: 40°C/75% RH


Entry 39 - fullUrl = urn:uuid:72e0640b-094b-909e-5268-3dee92af4bbd

Resource Observation:

Generated Narrative: Observation

Resource Observation "72e0640b-094b-909e-5268-3dee92af4bbd"

Triggered by: See above (ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50)

status: FINAL

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

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

specimen: See above (Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785)

hasMember:

instantiates: See above (ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.143 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.243 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: <0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

instantiates: See above (ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.801 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

instantiates: See above (ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c)

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: 0.1501 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()

instantiates: See above (ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8)

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: See above (Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)

value: Complies ()


Generated Narrative: Observation #Accelerated40C-3-1-Description

instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp1

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.143 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 1 ()

Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp2

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.243 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp3

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.201 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 3 ()

Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impUnspecified

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: <0.101 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Degradation Impurity ()

Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impTotal

instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.801 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Degradation Impurities ()

Generated Narrative: Observation #Accelerated40C-3-1-Water

instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c

status: FINAL

code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: 0.1501 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #Accelerated40C-3-1-Microbiological

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Microbiological Quality (CodeSystem - Example Local Codes - Drug#Microbiological Quality)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Generated Narrative: Observation #Accelerated40C-3-1-Uniformity

instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8

status: FINAL

code: Uniformity of dosage units (by weight) (CodeSystem - Example Local Codes - Drug#uniformity-dosage)

subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c

effective: 2023-01-01 12:00:00+0000

performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9

value: Complies ()


Entry 40 - fullUrl = urn:uuid:7ef62d57-7cc6-9211-66d6-abc7e096093c

Resource Medication:

Generated Narrative: Medication

Resource Medication "7ef62d57-7cc6-9211-66d6-abc7e096093c"

Profile: Medication - Batch Information Drug PQ

code: ()

Batches

-ExtensionLotNumber
*, , , , , 33445


Entry 41 - fullUrl = urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9

Resource Medication:

Generated Narrative: Medication

Resource Medication "8306cfc5-158f-1a53-a683-048b226060d9"

code: ()

Batches

-ExtensionLotNumber
*, , , , , 33446


Entry 42 - fullUrl = urn:uuid:f54d4666-7ae3-4e30-8c5a-6d13838c4f3b

Resource Medication:

Generated Narrative: Medication

Resource Medication "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b"

code: ()

Batches

-ExtensionLotNumber
*, , , , , 33447


Entry 43 - fullUrl = urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd

Resource Organization:

Generated Narrative: Organization

Resource Organization "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"

identifier: urn:oid:2.16.840.1.113883.4.82/3010027650

name: AAA Pharmaceutical, Inc.

Contacts

-Address
*681 Main Street Lumberton New Jersey 08048 USA


Entry 44 - fullUrl = urn:uuid:2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc

Resource Organization:

Generated Narrative: Organization

Resource Organization "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc"

name: MySite


Entry 45 - fullUrl = urn:uuid:e3d2bc19-2f10-2b4d-1741-e4135fe612a9

Resource Organization:

Generated Narrative: Organization

Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9"

identifier: urn:oid:2.16.840.1.113883.4.82/3007270600

name: Advanced Analytical Testing Laboratories Inc.

Contacts

-Address
*30 Silverline Drive North Brunswick New Jersey 08902 USA


Entry 46 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"

Profile: MedicinalProductDefinition - Drug Product PQ

description: Textual description of the product

combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)

route: Oral use (standardterms.edqm.eu#20053000)

name

productName: Stelbat Tablets, 20mg

type: Proprietary (CodeSystem - Product Name Type#Proprietary)

Parts

-PartType
*20mgStrength part (Product Name Part Type#StrengthPart)


Entry 47 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6

Resource Ingredient:

Generated Narrative: Ingredient

Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"

Profile: Ingredient - Drug Pq

status: ACTIVE

for: See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)

role: Active (Ingredient Role#100000072072)

substance

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)


Entry 48 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390"

Profile: SubstanceDefinition - Component Substance Drug PQ

manufacturer: See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)

Names

-Name
*Stelbatolol


Entry 49 - fullUrl = urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c

Resource Organization:

Generated Narrative: Organization

Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c"

Profile: Organization - Drug PQ

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

-Address
*7233 W 116th Pl Ste C Broomfield Colorado 80020 USA


Entry 50 - fullUrl = urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b

Resource Substance:

Generated Narrative: Substance

Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b"

Profile: Substance - Drug PQ

Medication Manufacturing Batch

url

manufacturingDate

value: 2019-09-07

url

batchQuantity

value: 5 kg

url

batchUtilization

value: Development (NCI Thesaurus#C133991)

url

assignedManufacturer

value: See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT1

instance: true

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)


Entry 51 - fullUrl = urn:uuid:cb31d747-2338-88d5-342c-8e9c097e4dad

Resource Substance:

Generated Narrative: Substance

Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad"

Medication Manufacturing Batch

url

manufacturingDate

value: 2019-09-07

url

batchQuantity

value: 5 kg

url

batchUtilization

value: Development (NCI Thesaurus#C133991)

url

assignedManufacturer

value: See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT2

instance: true

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)


Entry 52 - fullUrl = urn:uuid:1551f97b-6f6d-825e-1fb3-44b0b090808c

Resource Substance:

Generated Narrative: Substance

Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c"

Medication Manufacturing Batch

url

manufacturingDate

value: 2019-09-07

url

batchQuantity

value: 5 kg

url

batchUtilization

value: Development (NCI Thesaurus#C133991)

url

assignedManufacturer

value: See above (Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c)

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT3

instance: true

Codes

-Reference
*See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)