Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
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: https://eudract.europa.eu/example/identifier/PLO555Report 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-aa8afafc9c5btitle: Stability Monitoring Program
type: Stability Study Protocol (Pharmaceutical Plan Type Codes#1244588)
status: ACTIVE
subject: See on this page: 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/643d8b44-71f4-2b58-07e8-51c22b294b25status: 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-2f71-9a10-642e5a0a5d42title: 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-7f0db9696a1etitle: 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-d4be24f303d3title: 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-f46b1a662201title: 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-6fc3-88d3-7d38-0afcf13c4f67title: 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-5780-5f5c79a47f12title: 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-0d65718860f2title: 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-3a7767a38149title: 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-e9202fee8cbatitle: X
status: ACTIVE
code: Battery of tests 'X' at 30°C/65% RH ()
specimen: See on this page: SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25
hasMember:
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-ce2715f08d69title: Description
status: ACTIVE
code: Description (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-133e23b97119title: Assay (% w/w) (Mean)
status: ACTIVE
code: Assay (% w/w) (Mean) (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-a0b8-31b6-1165-346563b9305etitle: Drug-related Impurities Content by LC (% w/w)
status: ACTIVE
code: Impurities (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 (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-94e9bb75876etitle: Y
status: ACTIVE
code: Battery of tests 'Y' at 30°C/65% RH ()
specimen: See on this page: SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25
hasMember: See on this page: 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-d6c49360230btitle: Identification
status: ACTIVE
code: Identification (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-e7ca814253e1status: 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-e35866ef8495title: 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/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9title: 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-8768-4251b1ad0817title: 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/35fa7b97-98d3-35d3-5672-4ab1047d57fctitle: X
status: ACTIVE
code: Battery of tests 'X' at 40°C/75% RH ()
specimen: See on this page: SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1
hasMember:
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/accb8802-4223-61e2-8c79-2282e22a2bb6title: Y
status: ACTIVE
code: Battery of tests 'Y' at 40°C/75% RH ()
specimen: See on this page: SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1
hasMember: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
Entry 24 - fullUrl = urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5
Resource 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 on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.15 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.05 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.8 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (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 (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 (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 (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 (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 (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 (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 (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:
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 on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/3b550915-4467-83d3-340f-9bd6d2857191
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.152 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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:
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 on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42
status: FINAL
code: Test Components - Long-term 25C etc - Initial (XYZ) ()
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.152 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.12 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.22 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.052 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.82 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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 (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:
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:
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:
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 on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (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 (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 (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 (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 (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 (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 (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 (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 on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/872a645f-120e-44c0-62c0-9be05acf543b
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (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 (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 (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 (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 (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 (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 (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 (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 on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12
status: FINAL
code: Long-term - 30°C/65% RH - 18 months (X) ()
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Complies ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.118 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.218 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0518 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.818 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (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 (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 (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 (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 (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 (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 (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 (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:
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 on this page: ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9
status: FINAL
code: Accelerated - 40°C/67% RH - 3 months (X) ()
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
specimen: See on this page: Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30
hasMember:
instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: Doesn't comply ()
instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.113 % w/w (Details: UCUM code % = '%')
instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Degradation Products (Example Local Codes - Drug#DGP)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.113 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.213 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: <0.0513 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.813 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 (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 (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 (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2
instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
status: FINAL
code: Impurities (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 (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 (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 (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 (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 (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 (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 (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:
urn:oid:2.16.840.1.113883.4.82/3003040516active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 39 - fullUrl = urn:uuid:6049d921-9935-90b7-4efc-894a66483c00
Resource Organization:
Generated Narrative: Organization
Resource Organization "6049d921-9935-90b7-4efc-894a66483c00"
identifier:
urn:oid:2.16.840.1.113883.4.82/3007270600active: true
type: Analytical Testing - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability)
name: Advanced Analytical Testing Laboratories Inc.
Contacts
Address 30 Silverline Drive North Brunswick New Jersey 08902 USA
Entry 40 - fullUrl = urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "2e3a85b5-790a-a108-3627-edf0ec6f1210"
identifier:
http://example.company.org/companySubstanceIdentifier/4444455555manufacturer: See on this page: 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:
urn:oid:2.16.840.1.113883.4.82/3003040516active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 42 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08
Resource Organization:
Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"
identifier:
urn:oid:2.16.840.1.113883.4.82/3007270600active: true
type: Analytical Testing - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability)
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
manufacturingDatevalue: 2020-01
url
batchQuantityvalue: 120 kg
url
batchUtilizationvalue: Production (NCI Thesaurus#C133990 "Commercial")
url
assignedManufacturervalue: See on this page: Organization/e2359a4e-3091-23f8-2242-87e701830d55
url
containerExtension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: CAT1
instance: true
Codes
Reference See on this page: SubstanceDefinition/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
manufacturingDatevalue: 2020-02
url
batchQuantityvalue: 120 kg
url
batchUtilizationvalue: Production (NCI Thesaurus#C133990 "Commercial")
url
assignedManufacturervalue: See on this page: 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: CAT2
instance: true
Codes
Reference See on this page: 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
manufacturingDatevalue: 2020-03
url
batchQuantityvalue: 120 kg
url
batchUtilizationvalue: Production (NCI Thesaurus#C133990 "Commercial")
url
assignedManufacturervalue: See on this page: 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: CAT3
instance: true
Codes
Reference See on this page: SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
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