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

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

Example Bundle: Example: Bundle – Batch Analysis, substance

Bundle bundle-batch-analysis-pq-ex2-sub of type collection


Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f"

Profile: PlanDefinition - Drug PQ

url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f

title: S.4.4 BATCH ANALYSIS

type: Specification Protocol (planType#1244577)

status: ACTIVE

subject: See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)

description: Narrative description of analysis

action

title: Batch Specification for Drug Substance

code: Overall set of actions ()

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
*Test ()ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
*Test ()ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
*Test ()ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
*Test ()ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
*Test ()ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
*Test ()ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
*Test ()ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
*Test ()ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4


Entry 2 - fullUrl = urn:uuid:13033a89-927a-10e0-503e-5f901bdca30f

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "13033a89-927a-10e0-503e-5f901bdca30f"

url: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f

title: Description

status: ACTIVE

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

method: Visual inspection ()

QualifiedValues

-Extension
*


Entry 3 - fullUrl = urn:uuid:8395ae1d-5064-0ab7-a297-6b20285b2230

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "8395ae1d-5064-0ab7-a297-6b20285b2230"

url: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230

title: Identification

status: ACTIVE

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

method: Identification by IR spectroscopy Identification by HPLC ()

QualifiedValues

-Extension
*


Entry 4 - fullUrl = urn:uuid:2117208e-4185-9091-1f86-cce37b121838

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "2117208e-4185-9091-1f86-cce37b121838"

url: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838

title: Assay

status: ACTIVE

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

method: Assay by LC ()

QualifiedValues

-Range
*98-102 % w/w


Entry 5 - fullUrl = urn:uuid:d04e0f2a-6ee7-6c2e-1db8-7df394c927b8

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"

url: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8

title: Drug Substance Related Organic impurities

status: ACTIVE

code: Drug Substance Related Organic impurities (CodeSystem - Example Local Codes - Drug#DGP-s)

method: Organic impurities by LC ()

qualifiedValue

appliesTo: Impurity 1 ()

range: ?-0.5

qualifiedValue

appliesTo: Impurity 2 ()

range: ?-0.5

qualifiedValue

appliesTo: Impurity 3 ()

range: ?-0.5

qualifiedValue

appliesTo: Any individual unspecified impurity ()

range: ?-0.10

qualifiedValue

appliesTo: Total impurities ()

range: ?-2.0

Components

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


Entry 6 - fullUrl = urn:uuid:0634020c-8729-99fc-7637-89799d7c445b

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "0634020c-8729-99fc-7637-89799d7c445b"

url: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b

title: Mutagenic impurities

status: ACTIVE

code: Mutagenic impurities (CodeSystem - Example Local Codes - Drug#MUT)

method: Impurity 5 content by LC-MS ()

QualifiedValues

-AppliesToRange
*Impurity - Mutagenic ()?-50

Components

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


Entry 7 - fullUrl = urn:uuid:4e67725b-20c8-158e-9d53-1810bfa58d87

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "4e67725b-20c8-158e-9d53-1810bfa58d87"

url: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87

title: Enantiomeric purity

status: ACTIVE

code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)

method: Enantiomeric purity by LC ()

QualifiedValues

-Range
*99.6-? %


Entry 8 - fullUrl = urn:uuid:2daba8ca-211f-4f4b-4028-16c30fe22ee8

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "2daba8ca-211f-4f4b-4028-16c30fe22ee8"

url: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8

title: Residual solvents

status: ACTIVE

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

method: Residual solvents by headspace GC ()

qualifiedValue

appliesTo: Solvent 1 ()

range: ?-0.1

qualifiedValue

appliesTo: Solvent 2 ()

range: ?-2.0

Components

-Code
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)


Entry 9 - fullUrl = urn:uuid:17b322fe-53ea-6c1f-521b-3b148ac05eb4

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "17b322fe-53ea-6c1f-521b-3b148ac05eb4"

url: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4

title: Water Content

status: ACTIVE

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

method: USP Karl Fischer titration ()

QualifiedValues

-Range
*?-1.0


Entry 10 - fullUrl = urn:uuid:11fcfe6b-7498-132b-2def-efae51b302d4

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "11fcfe6b-7498-132b-2def-efae51b302d4"

url: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4

title: Particle size distribution

status: ACTIVE

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

method: Laser diffraction ()

qualifiedValue

appliesTo: D(v,0.9) ()

range: ?-319

qualifiedValue

appliesTo: D(v,0.5) ()

range: ?-145

qualifiedValue

appliesTo: D(v,0.1) ()

range: ?-20

Components

-Code
*Particle size (CodeSystem - Example Local Codes - Drug#PARTS)


Entry 11 - fullUrl = urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1

Resource Substance:

Generated Narrative: Substance

Resource Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1"

Medication Manufacturing Batch

url

batchQuantity

value: 120 kg

url

manufacturingDate

value: 2020-01

url

batchUtilization

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

url

assignedManufacturer

value: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)

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

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

Extension - Manufacturing Process PQ: See above (PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975)

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT1

instance: true

Codes

-Reference
*See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)


Entry 12 - fullUrl = urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4

Resource Substance:

Generated Narrative: Substance

Resource Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4"

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-02

url

batchQuantity

value: 120 kg

url

batchUtilization

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

url

assignedManufacturer

value: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)

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

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

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT2

instance: true

Codes

-Reference
*See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)


Entry 13 - fullUrl = urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7

Resource Substance:

Generated Narrative: Substance

Resource Substance "ef17cff1-6586-a4a4-9168-2602140548d7"

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-03

url

batchQuantity

value: 120 kg

url

batchUtilization

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

url

assignedManufacturer

value: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)

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

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

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT3

instance: true

Codes

-Reference
*See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)


Entry 14 - fullUrl = urn:uuid:b30a1024-37db-a1bc-05e5-cc4596d92975

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "b30a1024-37db-a1bc-05e5-cc4596d92975"

url: http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975

title: Process 1.1

type: Manufacturing Process (planType#1244566)

status: ACTIVE

subject: See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)


Entry 15 - fullUrl = urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "8dae93e0-048d-35a4-71ea-7c603184a130"

manufacturer: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)

Names

-Name
*Stelbatolol


Entry 16 - fullUrl = urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330

Resource Organization:

Generated Narrative: Organization

Resource Organization "3d399cbc-244e-9b5f-838b-b7daa0489330"

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

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


Entry 17 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

Generated Narrative: Organization

Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"

name: Testing Lab


Entry 18 - fullUrl = urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006

Resource DiagnosticReport:

Batch Analysis Report

When For2020-12

Report Details

CodeValueNoteWhen For
DescriptionPass2023-01-01 12:00:00+0000
DescriptionPass2023-01-01 12:00:00+0000
DescriptionPass2023-01-01 12:00:00+0000
IdentificationConforms2023-01-01 12:00:00+0000
IdentificationDoes not conform2023-01-01 12:00:00+0000
IdentificationConforms2023-01-01 12:00:00+0000
Assay94 %CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%2023-01-01 12:00:00+0000
Assay95 %CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%2023-01-01 12:00:00+0000
Assay96 %CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%2023-01-01 12:00:00+0000
Impurities0.5 % w/w2023-01-01 12:00:00+0000
Impurities0.4 % w/w2023-01-01 12:00:00+0000
Impurities0.2 % w/w2023-01-01 12:00:00+0000
Impurities0.5 % w/w2023-01-01 12:00:00+0000
Impurities0.4 % w/w2023-01-01 12:00:00+0000
Impurities0.2 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Impurities0.5 % w/w2023-01-01 12:00:00+0000
Impurities0.4 % w/w2023-01-01 12:00:00+0000
Impurities0.2 % w/w2023-01-01 12:00:00+0000
Impurities0.5 % w/w2023-01-01 12:00:00+0000
Impurities0.4 % w/w2023-01-01 12:00:00+0000
Impurities0.2 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.1 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Impurities0.02 % w/w2023-01-01 12:00:00+0000
Mutagenic impurities20 ppm2023-01-01 12:00:00+0000
Mutagenic22 %2023-01-01 12:00:00+0000
Mutagenic18 %2023-01-01 12:00:00+0000
Enantiomeric purity91.5 %CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%2023-01-01 12:00:00+0000
Enantiomeric purity91.5 %CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%2023-01-01 12:00:00+0000
Enantiomeric purity91.5 %Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.2023-01-01 12:00:00+0000
Residual solvents0.1 % w/w2023-01-01 12:00:00+0000
Residual solvents0.1 % w/w2023-01-01 12:00:00+0000
Residual solvents0.1 % w/w2023-01-01 12:00:00+0000
Residual solvents1.4 % w/w2023-01-01 12:00:00+0000
Residual solvents1.5 % w/w2023-01-01 12:00:00+0000
Residual solvents1.2 % w/w2023-01-01 12:00:00+0000
Water Content0.8 % w/w2023-01-01 12:00:00+0000
Water Content0.8 % w/w2023-01-01 12:00:00+0000
Water Content0.8 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.5 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.4 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.2 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.5 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.4 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.2 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.1 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.1 % w/w2023-01-01 12:00:00+0000
Particle size distribution0.1 % w/w2023-01-01 12:00:00+0000

The samples have been assessed and the conclusion is...


Entry 19 - fullUrl = urn:uuid:81f552f9-8458-3cf4-8379-eea5417a9de2

Resource Observation:

Generated Narrative: Observation

Resource Observation "81f552f9-8458-3cf4-8379-eea5417a9de2"

instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)

status: FINAL

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

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Pass ()


Entry 20 - fullUrl = urn:uuid:50bf6f69-a3f5-678b-469b-c5df5cca4c86

Resource Observation:

Generated Narrative: Observation

Resource Observation "50bf6f69-a3f5-678b-469b-c5df5cca4c86"

instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)

status: FINAL

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

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Pass ()


Entry 21 - fullUrl = urn:uuid:145fd3b7-3678-867f-4298-a6c781b86de3

Resource Observation:

Generated Narrative: Observation

Resource Observation "145fd3b7-3678-867f-4298-a6c781b86de3"

instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)

status: FINAL

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

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Pass ()


Entry 22 - fullUrl = urn:uuid:55c89944-60d1-4eea-a2c3-6c53e3622bc5

Resource Observation:

Generated Narrative: Observation

Resource Observation "55c89944-60d1-4eea-a2c3-6c53e3622bc5"

instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Conforms ()


Entry 23 - fullUrl = urn:uuid:adb51ab6-00a9-1078-69e5-d32c025a857c

Resource Observation:

Generated Narrative: Observation

Resource Observation "adb51ab6-00a9-1078-69e5-d32c025a857c"

instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Does not conform ()


Entry 24 - fullUrl = urn:uuid:916a0ae2-9c43-72f0-a22a-c5f8ce902125

Resource Observation:

Generated Narrative: Observation

Resource Observation "916a0ae2-9c43-72f0-a22a-c5f8ce902125"

instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Conforms ()


Entry 25 - fullUrl = urn:uuid:6deb4306-1193-24ae-a565-f73225652bdd

Resource Observation:

Generated Narrative: Observation

Resource Observation "6deb4306-1193-24ae-a565-f73225652bdd"

instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 94 % (Details: UCUM code % = '%')

note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%


Entry 26 - fullUrl = urn:uuid:f6aabd2f-5902-57e7-6126-eccd9158a5b5

Resource Observation:

Generated Narrative: Observation

Resource Observation "f6aabd2f-5902-57e7-6126-eccd9158a5b5"

instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 95 % (Details: UCUM code % = '%')

note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%


Entry 27 - fullUrl = urn:uuid:32f598e4-a0e0-98dc-41dd-0f8397f953ad

Resource Observation:

Generated Narrative: Observation

Resource Observation "32f598e4-a0e0-98dc-41dd-0f8397f953ad"

instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 96 % (Details: UCUM code % = '%')

note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%


Entry 28 - fullUrl = urn:uuid:02d9e6be-833c-1c6d-a64a-baa3935c959d

Resource Observation:

Generated Narrative: Observation

Resource Observation "02d9e6be-833c-1c6d-a64a-baa3935c959d"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.5 % w/w (Details: UCUM code % = '%')

Components

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


Entry 29 - fullUrl = urn:uuid:d3e572b7-14fd-744b-4123-58741d75571e

Resource Observation:

Generated Narrative: Observation

Resource Observation "d3e572b7-14fd-744b-4123-58741d75571e"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.4 % w/w (Details: UCUM code % = '%')

Components

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


Entry 30 - fullUrl = urn:uuid:fe6ca484-a755-9a0b-a074-b6ee0a907ff8

Resource Observation:

Generated Narrative: Observation

Resource Observation "fe6ca484-a755-9a0b-a074-b6ee0a907ff8"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

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


Entry 31 - fullUrl = urn:uuid:da92c71f-a12a-1980-11a3-80e3d1852244

Resource Observation:

Generated Narrative: Observation

Resource Observation "da92c71f-a12a-1980-11a3-80e3d1852244"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.5 % w/w (Details: UCUM code % = '%')

Components

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


Entry 32 - fullUrl = urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6

Resource Observation:

Generated Narrative: Observation

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

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.4 % w/w (Details: UCUM code % = '%')

Components

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


Entry 33 - fullUrl = urn:uuid:31bfeff4-4a7d-3be5-878e-fb674d3d5487

Resource Observation:

Generated Narrative: Observation

Resource Observation "31bfeff4-4a7d-3be5-878e-fb674d3d5487"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

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


Entry 34 - fullUrl = urn:uuid:732237a9-4b3b-27cc-99ca-6b913e622a29

Resource Observation:

Generated Narrative: Observation

Resource Observation "732237a9-4b3b-27cc-99ca-6b913e622a29"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

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


Entry 35 - fullUrl = urn:uuid:52afbeb4-4958-a275-a0ca-d70b2b5240ec

Resource Observation:

Generated Narrative: Observation

Resource Observation "52afbeb4-4958-a275-a0ca-d70b2b5240ec"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

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


Entry 36 - fullUrl = urn:uuid:7fc395b1-59e4-78be-0512-cf92133c0fac

Resource Observation:

Generated Narrative: Observation

Resource Observation "7fc395b1-59e4-78be-0512-cf92133c0fac"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

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


Entry 37 - fullUrl = urn:uuid:9c98bd8a-7dda-2f01-0dbd-8c60b60e8572

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any individual unspecified impurity ()


Entry 38 - fullUrl = urn:uuid:97b16ff8-8e0f-915a-9d65-7fab108f40c2

Resource Observation:

Generated Narrative: Observation

Resource Observation "97b16ff8-8e0f-915a-9d65-7fab108f40c2"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any individual unspecified impurity ()


Entry 39 - fullUrl = urn:uuid:0244eafe-3126-909b-7d8d-4253f45f525c

Resource Observation:

Generated Narrative: Observation

Resource Observation "0244eafe-3126-909b-7d8d-4253f45f525c"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any individual unspecified impurity ()


Entry 40 - fullUrl = urn:uuid:10b80cbd-45d3-9be1-63b9-29f04b47376c

Resource Observation:

Generated Narrative: Observation

Resource Observation "10b80cbd-45d3-9be1-63b9-29f04b47376c"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.02 % w/w (Details: UCUM code % = '%')

Components

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


Entry 41 - fullUrl = urn:uuid:84f015ac-9572-324f-8013-0b999cc95bbd

Resource Observation:

Generated Narrative: Observation

Resource Observation "84f015ac-9572-324f-8013-0b999cc95bbd"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.02 % w/w (Details: UCUM code % = '%')

Components

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


Entry 42 - fullUrl = urn:uuid:987daeaa-4c2a-72b7-780f-4a9403163a3e

Resource Observation:

Generated Narrative: Observation

Resource Observation "987daeaa-4c2a-72b7-780f-4a9403163a3e"

instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.02 % w/w (Details: UCUM code % = '%')

Components

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


Entry 43 - fullUrl = urn:uuid:ff26533d-88a8-7f18-a275-42dc1373a388

Resource Observation:

Generated Narrative: Observation

Resource Observation "ff26533d-88a8-7f18-a275-42dc1373a388"

instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)

status: FINAL

code: Mutagenic impurities (CodeSystem - Example Local Codes - Drug#MUT)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 20 ppm (Details: UCUM code [ppm] = '[ppm]')

Components

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


Entry 44 - fullUrl = urn:uuid:c99666d2-7962-9a71-58f6-7b2e5aa662f5

Resource Observation:

Generated Narrative: Observation

Resource Observation "c99666d2-7962-9a71-58f6-7b2e5aa662f5"

instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)

status: FINAL

code: Mutagenic (CodeSystem - Example Local Codes - Drug#MUT "Mutagenic impurities")

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 22 % (Details: UCUM code % = '%')


Entry 45 - fullUrl = urn:uuid:c18e21d3-7113-4d08-4ff3-0c9718596f64

Resource Observation:

Generated Narrative: Observation

Resource Observation "c18e21d3-7113-4d08-4ff3-0c9718596f64"

instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)

status: FINAL

code: Mutagenic (CodeSystem - Example Local Codes - Drug#MUT "Mutagenic impurities")

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 18 % (Details: UCUM code % = '%')


Entry 46 - fullUrl = urn:uuid:66fdac46-2a6b-a66f-891b-8dcf67cc46c7

Resource Observation:

Generated Narrative: Observation

Resource Observation "66fdac46-2a6b-a66f-891b-8dcf67cc46c7"

instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)

status: FINAL

code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 91.5 % (Details: UCUM code % = '%')

note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%


Entry 47 - fullUrl = urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9

Resource Observation:

Generated Narrative: Observation

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

instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)

status: FINAL

code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 91.5 % (Details: UCUM code % = '%')

note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%


Entry 48 - fullUrl = urn:uuid:fc49ad55-07d1-997d-6695-bbff44746e75

Resource Observation:

Generated Narrative: Observation

Resource Observation "fc49ad55-07d1-997d-6695-bbff44746e75"

instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)

status: FINAL

code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 91.5 % (Details: UCUM code % = '%')

note: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.


Entry 49 - fullUrl = urn:uuid:f8160692-a7a8-3fa6-9f35-e7df35f51ac0

Resource Observation:

Generated Narrative: Observation

Resource Observation "f8160692-a7a8-3fa6-9f35-e7df35f51ac0"

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 1 ()


Entry 50 - fullUrl = urn:uuid:a531aee9-4c21-06af-352c-a3615b5d957e

Resource Observation:

Generated Narrative: Observation

Resource Observation "a531aee9-4c21-06af-352c-a3615b5d957e"

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 1 ()


Entry 51 - fullUrl = urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd

Resource Observation:

Generated Narrative: Observation

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

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 1 ()


Entry 52 - fullUrl = urn:uuid:ba8a182e-8571-6cbd-047b-612735d599d2

Resource Observation:

Generated Narrative: Observation

Resource Observation "ba8a182e-8571-6cbd-047b-612735d599d2"

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 1.4 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 2 ()


Entry 53 - fullUrl = urn:uuid:0b5b94cc-7a1a-4ada-66c7-954ceb528d67

Resource Observation:

Generated Narrative: Observation

Resource Observation "0b5b94cc-7a1a-4ada-66c7-954ceb528d67"

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 1.5 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 2 ()


Entry 54 - fullUrl = urn:uuid:6afaacee-11a6-58b2-47df-5f79722c66ac

Resource Observation:

Generated Narrative: Observation

Resource Observation "6afaacee-11a6-58b2-47df-5f79722c66ac"

instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)

status: FINAL

code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 1.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Solvent (CodeSystem - Example Local Codes - Drug#SOLV)Solvent 2 ()


Entry 55 - fullUrl = urn:uuid:c2644a86-1684-286e-00e2-dcaf907a8970

Resource Observation:

Generated Narrative: Observation

Resource Observation "c2644a86-1684-286e-00e2-dcaf907a8970"

instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)

status: FINAL

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

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.8 % w/w (Details: UCUM code % = '%')


Entry 56 - fullUrl = urn:uuid:cb5f6872-6eeb-727a-7c33-f2c438581a1c

Resource Observation:

Generated Narrative: Observation

Resource Observation "cb5f6872-6eeb-727a-7c33-f2c438581a1c"

instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)

status: FINAL

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

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.8 % w/w (Details: UCUM code % = '%')


Entry 57 - fullUrl = urn:uuid:7faaf980-7c10-7b9a-9572-1bacd485824e

Resource Observation:

Generated Narrative: Observation

Resource Observation "7faaf980-7c10-7b9a-9572-1bacd485824e"

instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)

status: FINAL

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

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.8 % w/w (Details: UCUM code % = '%')


Entry 58 - fullUrl = urn:uuid:e4d2118a-8562-9eb1-2c14-4e145d2a95fc

Resource Observation:

Generated Narrative: Observation

Resource Observation "e4d2118a-8562-9eb1-2c14-4e145d2a95fc"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.5 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)D(v,0.9) ()


Entry 59 - fullUrl = urn:uuid:ec078717-9512-4db4-77c6-2c7e29d213a6

Resource Observation:

Generated Narrative: Observation

Resource Observation "ec078717-9512-4db4-77c6-2c7e29d213a6"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.4 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)D(v,0.9) ()


Entry 60 - fullUrl = urn:uuid:05cfb495-2580-561a-688d-ce6ea24c8962

Resource Observation:

Generated Narrative: Observation

Resource Observation "05cfb495-2580-561a-688d-ce6ea24c8962"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.9) ()


Entry 61 - fullUrl = urn:uuid:d2a60ae5-96b4-3d13-38da-729c652347a3

Resource Observation:

Generated Narrative: Observation

Resource Observation "d2a60ae5-96b4-3d13-38da-729c652347a3"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.5 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.5) ()


Entry 62 - fullUrl = urn:uuid:c3f51325-2f5f-194c-919b-2219ee1f5c45

Resource Observation:

Generated Narrative: Observation

Resource Observation "c3f51325-2f5f-194c-919b-2219ee1f5c45"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.4 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.5) ()


Entry 63 - fullUrl = urn:uuid:e9d89693-11b1-13ed-5cde-606fc1b8372c

Resource Observation:

Generated Narrative: Observation

Resource Observation "e9d89693-11b1-13ed-5cde-606fc1b8372c"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.5) ()


Entry 64 - fullUrl = urn:uuid:2659b000-96e2-1b8b-129b-0c00e1074b0f

Resource Observation:

Generated Narrative: Observation

Resource Observation "2659b000-96e2-1b8b-129b-0c00e1074b0f"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.1) ()


Entry 65 - fullUrl = urn:uuid:10b47328-36fa-343d-5699-5b32b30a6d33

Resource Observation:

Generated Narrative: Observation

Resource Observation "10b47328-36fa-343d-5699-5b32b30a6d33"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.1) ()


Entry 66 - fullUrl = urn:uuid:e6780766-317a-382f-92d2-79825f506cc5

Resource Observation:

Generated Narrative: Observation

Resource Observation "e6780766-317a-382f-92d2-79825f506cc5"

instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)

status: FINAL

code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)

subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)

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

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

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

Components

-CodeValue[x]
*Particle Size (CodeSystem - Example Local Codes - Drug#SIZE)D(v,0.1) ()