Example: Bundle – Stability, substance - Pharmaceutical Quality (Industry) v1.0.0-ballot

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Example Bundle: Example: Bundle – Stability, substance

Bundle bundle-drug-stability-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003

Resource DiagnosticReport:

Stability Study Report
When For 2019-09-08
Identifier: id: PLO555
Report Details
Code Value When 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
Long-term - 30°C/65% RH - 18 months (X) 2023-01-01 12:00:00+0000
Long-term - 30°C/65% RH - 18 months (X) 2023-01-01 12:00:00+0000
Long-term - 30°C/65% RH - 18 months (X) 2023-01-01 12:00:00+0000
Accelerated - 40°C/67% RH - 3 months (X) 2023-01-01 12:00:00+0000
The samples have been assessed and the conclusion is...

Entry 2 - fullUrl = urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "c3973835-10ca-0796-0a26-aa8afafc9c5b"
url: http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b
title: Stability Monitoring Program
type: Stability Study Protocol (planType#1244588)
status: ACTIVE
subject: See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)
description: Description of the study study plan which includes tests, time points, storage conditions, method
action
title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol
action
action

Entry 3 - fullUrl = urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition
Resource SpecimenDefinition "643d8b44-71f4-2b58-07e8-51c22b294b25"
url: http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25
status: ACTIVE
typeTested
preference: PREFERRED
Handlings
- Instruction
* 30°C/65% RH

Entry 4 - fullUrl = urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "10d7b693-7a0e-2f71-9a10-642e5a0a5d42"
url: http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42
title: Long-term - 30°C/65% RH - XY
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba, http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e

Entry 5 - fullUrl = urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "480a61f8-14b3-233e-8e5f-7f0db9696a1e"
url: http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 6 - fullUrl = urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "bee486c4-6ab5-6293-4114-d4be24f303d3"
url: http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 7 - fullUrl = urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "99893d3c-520c-8d7b-6d73-f46b1a662201"
url: http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 8 - fullUrl = urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"
url: http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 9 - fullUrl = urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "c9b53a46-2f61-7b3f-5780-5f5c79a47f12"
url: http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 10 - fullUrl = urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"
url: http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 11 - fullUrl = urn:uuid:75073965-82eb-407d-34cf-3a7767a38149

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "75073965-82eb-407d-34cf-3a7767a38149"
url: http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149
title: Long-term - 30°C/65% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

Entry 12 - fullUrl = urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "18762cff-9e29-6e71-1184-e9202fee8cba"
url: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
title: X
status: ACTIVE
code: Battery of tests 'X' at 30°C/65% RH ()
specimen: See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)
hasMember:
See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

Entry 13 - fullUrl = urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "559ffdc3-349b-a4a3-a651-ce2715f08d69"
url: http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
title: Description
status: ACTIVE
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
QualifiedValues
- Extension
*

Entry 14 - fullUrl = urn:uuid:7943795a-2abe-666f-545f-133e23b97119

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "7943795a-2abe-666f-545f-133e23b97119"
url: http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
title: Assay (% w/w) (Mean)
status: ACTIVE
code: Assay (% w/w) (Mean) (CodeSystem - Example Local Codes - Drug#ASSAY "Assay")
QualifiedValues
- Range
* 98-102 % w/w

Entry 15 - fullUrl = urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e"
url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
title: Drug-related Impurities Content by LC (% w/w)
status: ACTIVE
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
qualifiedValue
appliesTo: Impurity ()
range: ?-0.5
qualifiedValue
appliesTo: Impurity 2 ()
range: ?-0.52
qualifiedValue
appliesTo: Any Unspecified Impurity ()
range: ?-0.10
qualifiedValue
appliesTo: Total Impurities ()
range: ?-2.0
Components
- Code
* Impurity (CodeSystem - Example Local Codes - Drug#IMP)

Entry 16 - fullUrl = urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "31abea79-81da-17f8-9d8c-94e9bb75876e"
url: http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e
title: Y
status: ACTIVE
code: Battery of tests 'Y' at 30°C/65% RH ()
specimen: See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)
hasMember: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

Entry 17 - fullUrl = urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b"
url: http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
title: Identification
status: ACTIVE
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
QualifiedValues
- Extension
*

Entry 18 - fullUrl = urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition
Resource SpecimenDefinition "306637ec-1041-80e8-8e77-e7ca814253e1"
url: http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1
status: ACTIVE
typeTested
preference: PREFERRED
Handlings
- Instruction
* 40°C/75% RH

Entry 19 - fullUrl = urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "1b43a536-3c29-3427-0b93-e35866ef8495"
url: http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495
title: Accelerated - 40°C/70% RH - XY
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc, http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6

Entry 20 - fullUrl = urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"
url: http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9
title: Accelerated - 40°C/70% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc

Entry 21 - fullUrl = urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition
Resource ActivityDefinition "cf2f00df-971f-0bab-8768-4251b1ad0817"
url: http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817
title: Accelerated - 40°C/70% RH - X
status: ACTIVE
observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc

Entry 22 - fullUrl = urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "35fa7b97-98d3-35d3-5672-4ab1047d57fc"
url: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc
title: X
status: ACTIVE
code: Battery of tests 'X' at 40°C/75% RH ()
specimen: See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)
hasMember:
See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

Entry 23 - fullUrl = urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "accb8802-4223-61e2-8c79-2282e22a2bb6"
url: http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6
title: Y
status: ACTIVE
code: Battery of tests 'Y' at 40°C/75% RH ()
specimen: See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)
hasMember: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

Entry 24 - fullUrl = urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "6a5354bf-602c-99f1-324b-0bb5f7e06cd5"
Collections
- Collected[x]
* 2020-06
processing
description: No storage
processing
description: 25°C/60% RH

Entry 25 - fullUrl = urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c

Resource Observation:

Generated Narrative: Observation
Resource Observation "588a6787-0454-55ef-0b8a-4c8941b6976c"
Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.15 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.05 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.8 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()
Generated Narrative: Observation #LongTerm30C-initial-1-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-initial-1-Impurity1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.05 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.8 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-initial-1-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.15 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-initial-1-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()

Entry 26 - fullUrl = urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "3b550915-4467-83d3-340f-9bd6d2857191"
Collections
- Collected[x]
* 2020-06
processing
description: No storage
processing
description: 25°C/60% RH

Entry 27 - fullUrl = urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf

Resource Observation:

Generated Narrative: Observation
Resource Observation "930c7f69-2546-7148-2069-b3be3a755edf"
Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/3b550915-4467-83d3-340f-9bd6d2857191)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.152 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Does not comply ()
Generated Narrative: Observation #LongTerm30C-initial-2-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-initial-2-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.152 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-initial-2-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Does not comply ()

Entry 28 - fullUrl = urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"
Collections
- Collected[x]
* 2020-06
processing
description: No storage
processing
description: 25°C/60% RH

Entry 29 - fullUrl = urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4

Resource Observation:

Generated Narrative: Observation
Resource Observation "8070745c-30c4-a52e-41fd-600a913578d4"
Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.152 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Does not comply ()
Generated Narrative: Observation #LongTerm30C-initial-3-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-initial-3-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.152 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-initial-3-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Does not comply ()

Entry 30 - fullUrl = urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"
Collections
- Collected[x]
* 2020-06
processing
description: Store for 18 months
time: 2020-12 --> 2022-06
processing
description: 30°C/65% RH

Entry 31 - fullUrl = urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "872a645f-120e-44c0-62c0-9be05acf543b"
Collections
- Collected[x]
* 2020-06
processing
description: Store for 18 months
time: 2020-12 --> 2022-06
processing
description: 30°C/65% RH

Entry 32 - fullUrl = urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "7c06a03c-9cf7-2e1b-a236-d60038f1439b"
Collections
- Collected[x]
* 2020-06
processing
description: Store for 18 months
time: 2020-12 --> 2022-06
processing
description: 30°C/65% RH

Entry 33 - fullUrl = urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900

Resource Observation:

Generated Narrative: Observation
Resource Observation "f16113fe-27e7-0aa2-6787-9415f5051900"
Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-1-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-1-Impurity1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-18m-1-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-18m-1-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()

Entry 34 - fullUrl = urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904

Resource Observation:

Generated Narrative: Observation
Resource Observation "1b25eb25-9149-02f6-9676-c87f90c64904"
Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/872a645f-120e-44c0-62c0-9be05acf543b)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-2-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-2-Impurity1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-18m-2-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-18m-2-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()

Entry 35 - fullUrl = urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377

Resource Observation:

Generated Narrative: Observation
Resource Observation "004ed877-7729-834e-3b6b-a2cf4bdb2377"
Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-3-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
Generated Narrative: Observation #LongTerm30C-18m-3-Impurity1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #LongTerm30C-18m-3-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #LongTerm30C-18m-3-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()

Entry 36 - fullUrl = urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30

Resource Specimen:

Generated Narrative: Specimen
Resource Specimen "b04c9321-069c-4da8-8ed0-86337ea22c30"
Collections
- Collected[x]
* 2020-06
processing
description: No storage
processing
description: 40°C/75% RH

Entry 37 - fullUrl = urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd

Resource Observation:

Generated Narrative: Observation
Resource Observation "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"
Triggered by: See above (ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9)
status: FINAL
code: Accelerated - 40°C/67% RH - 3 months (X) ()
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
specimen: See above (Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30)
hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Doesn't comply ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.113 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.113 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.213 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: <0.0513 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.813 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Complies ()
Generated Narrative: Observation #Accelerated40C-3m-1-Description
instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Doesn't comply ()
Generated Narrative: Observation #Accelerated40C-3m-1-Impurity1
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.113 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity ()
Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.213 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityUnspecified
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0513 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any Unspecified Impurity ()
Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityTotal
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.813 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total Impurities ()
Generated Narrative: Observation #Accelerated40C-3m-1-Assay
instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.113 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation #Accelerated40C-3m-1-Identification
instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()

Entry 38 - fullUrl = urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181

Resource Organization:

Generated Narrative: Organization
Resource Organization "62c1b1b4-8d15-26d2-57f9-25a2f60b6181"
identifier: id: 3003040516
name: AAA Molybdenum Products, Inc.
Contacts
- Address
* 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 39 - fullUrl = urn:uuid:6049d921-9935-90b7-4efc-894a66483c00

Resource Organization:

Generated Narrative: Organization
Resource Organization "6049d921-9935-90b7-4efc-894a66483c00"
identifier: id: 3007270600
name: Advanced Analytical Testing Laboratories Inc.
Contacts
- Address
* 30 Silverline Drive North Brunswick New Jersey 08902 USA

Entry 40 - fullUrl = urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "2e3a85b5-790a-a108-3627-edf0ec6f1210"
identifier: id: 4444455555
manufacturer: See above (Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181)
Names
- Name
* Stelbatolol

Entry 41 - fullUrl = urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55

Resource Organization:

Generated Narrative: Organization
Resource Organization "e2359a4e-3091-23f8-2242-87e701830d55"
identifier: id: 3003040516
name: AAA Molybdenum Products, Inc.
Contacts
- Address
* 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 42 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"
name: Testing Lab

Entry 43 - fullUrl = urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87

Resource Substance:

Generated Narrative: Substance
Resource Substance "a3fdc23b-6c16-2e65-481e-3fc895b37b87"
Medication Manufacturing Batch
url
manufacturingDate
value: 2020-01
url
batchQuantity
value: 120 kg
url
batchUtilization
value: Production (NCI Thesaurus#C133990 "Commercial")
url
assignedManufacturer
value: See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)
url
container
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT1
instance: true
Codes
- Reference
* See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)

Entry 44 - fullUrl = urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d

Resource Substance:

Generated Narrative: Substance
Resource Substance "cbcecab6-374c-396f-29be-877da7285e8d"
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 above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT2
instance: true
Codes
- Reference
* See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)

Entry 45 - fullUrl = urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd

Resource Substance:

Generated Narrative: Substance
Resource Substance "ae1f3b4c-4f14-1460-6903-7260959ea2cd"
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 above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT3
instance: true
Codes
- Reference
* See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)