Pharmaceutical Quality (Industry)
1.0.0 - STU1

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

## Example Bundle: Example: Bundle – Stability, 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: | `https://eudract.europa.eu/example/identifier`/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 (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/643d8b44-71f4-2b58-07e8-51c22b294b25`

> 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 on this page: SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25

> hasMember:

> - See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
> - See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
> - See on this page: 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 (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) (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 (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-94e9bb75876e`

> title: 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-d6c49360230b`

> title: 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-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 on this page: SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1

> hasMember:

> - See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69
> - See on this page: 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 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:

> 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 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:

> 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 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:

> 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 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:

> 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 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:

> 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 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`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

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

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`/3007270600

> active: true

> type: Analytical Testing - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability)

> name: Advanced Analytical Testing Laboratories Inc.

> ### Contacts

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

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`/4444455555

> manufacturer: 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`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

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

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`/3007270600

> active: 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

> > > `manufacturingDate`

> > value: 2020-01

> > > url

> > > `batchQuantity`

> > value: 120 kg

> > > url

> > > `batchUtilization`

> > value: Production (NCI Thesaurus#C133990 "Commercial")

> > > url

> > > `assignedManufacturer`

> > value: See on this page: 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: 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

> > > `manufacturingDate`

> > value: 2020-02

> > > url

> > > `batchQuantity`

> > value: 120 kg

> > > url

> > > `batchUtilization`

> > value: Production (NCI Thesaurus#C133990 "Commercial")

> > > url

> > > `assignedManufacturer`

> > value: See on this page: Organization/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

> > > `manufacturingDate`

> > value: 2020-03

> > > url

> > > `batchQuantity`

> > value: 120 kg

> > > url

> > > `batchUtilization`

> > value: Production (NCI Thesaurus#C133990 "Commercial")

> > > url

> > > `assignedManufacturer`

> > value: See on this page: Organization/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