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 – Substance Characterization

Bundle bundle-drug-substance-characterization-pq-ex1 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"

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

title: Elucidation of Structure

type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#elucidation-of-structure "Elucidation of Structure")

status: ACTIVE

subject: See above (SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390)

description: Pre-defined validation acceptance criteria were established based on manufacturing development data derived from process characterization studies...

action

prefix: 1

title: Elemental Analyis

description: Description of this step

code: Elemental Analyis (CodeSystem - Characterization Step#elemental-analyis)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e73
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e74
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e75

action

prefix: 2

title: List of Theoretical and Observed HCD MS/MS Ions

description: Description of this step

code: Ion Analyis (CodeSystem - Characterization Step#ion-analyis)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c3-2d06-47cb5b295e72
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c4-2d06-47cb5b295e72
*Test ()ObservationDefinition/fd18b5d6-9fe1-91c4-2d06-47cb5b295e72
*Test ()ObservationDefinition/fd17b5d6-9fe1-91c5-2d06-47cb5b295e72

action

prefix: 2.3.fig7

title: Structure of Stelbatolol With Number Assignments

description: Description of this step

code: Structure (CodeSystem - Characterization Step#structure)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e72

action

prefix: 3

title: Interpretation of the 1D 1H NMR and 13C NMR Spectra of Stelbatolol in DMSO-d6

description: Description of this step

code: NMR (CodeSystem - Characterization Step#nmr)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72

action

prefix: 2.6.fig10

title: Molecular Structure of Stalbatalol (Lot SUB1Amgen) Determined by Single Crystal X-ray Diffraction Analysis

description: Description of this step

code: Molecular Structure (CodeSystem - Characterization Step#MolecularStructure)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e74

action

prefix: 3.2.fig11

title: X-ray Powder Diffractogram of Stalbatolol (Lot SUB1Amgen)

description: Description of this step

code: Diffractogram (CodeSystem - Characterization Step#diffractogram)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e73

action

prefix: 2.4.fig9

title: UV/Visible Absorption Spectrum of Stelbataol (Lot SUB1Amgen)

description: Description of this step

code: Absorption (CodeSystem - Characterization Step#absorption)

Actions

-CodeDefinition[x]
*Test ()ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e75


Entry 2 - fullUrl = urn:uuid:b664977d-799d-a1ce-928a-5def2a9955bd

Resource DiagnosticReport:

Characterization Report

When For2020-12

Report Details

CodeValueWhen For
Elemental Analysis Carbon (%)83.75 %2023-01-01 12:00:00+0000
Elemental Analysis Hydrogen (%)2.75 %2023-01-01 12:00:00+0000
Elemental Analysis Nitrogen (%)5.55 %2023-01-01 12:00:00+0000
Elemental Analysis Flourine (%)7.75 %2023-01-01 12:00:00+0000
Ion Analysis Carbon (%)1.1252023-01-01 12:00:00+0000
Ion Analysis Hydrogen (%)2.1252023-01-01 12:00:00+0000
Ion Analysis Nitrogen (%)3.1252023-01-01 12:00:00+0000
Ion Analysis Flourine (%)4.1252023-01-01 12:00:00+0000
Chemical StructureNo display for Attachment2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
NMR2023-01-01 12:00:00+0000
AbsorptionNo display for Attachment2023-01-01 12:00:00+0000
MolecularStructureNo display for Attachment2023-01-01 12:00:00+0000
X-Ray Powder DiffractogramNo display for Attachment2023-01-01 12:00:00+0000

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


Entry 3 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72

title: C

status: ACTIVE

code: Elemental Analysis Carbon (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisCarbon)

QualifiedValues

-ExtensionRange
*83.75-83.75 %


Entry 4 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e73

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e73"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e73

title: H

status: ACTIVE

code: Elemental Analysis Hydrogen (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisHydrogen)

QualifiedValues

-ExtensionRange
*2.75-2.75 %


Entry 5 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e74

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e74"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e74

title: N

status: ACTIVE

code: Elemental Analysis Nitrogen (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisNitrogen)

QualifiedValues

-ExtensionRange
*5.55-5.55 %


Entry 6 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c2-2d06-47cb5b295e75

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c2-2d06-47cb5b295e75"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e75

title: F

status: ACTIVE

code: Elemental Analysis Flourine (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisFlourine)

QualifiedValues

-ExtensionRange
*7.75-7.75 %


Entry 7 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c3-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c3-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c3-2d06-47cb5b295e72

title: C

status: ACTIVE

code: Ion Analysis Carbon (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisCarbon)

QualifiedValues

-ExtensionRange
*1.125-1.125

Components

-Code
*Ion Analysis Carbon - Mass Accuracy (CodeSystem - Example Local Codes - Drug#IonAnalysisCarbonMassAccuracy)


Entry 8 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c4-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c4-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c4-2d06-47cb5b295e72

title: H

status: ACTIVE

code: Ion Analysis Hydrogen (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisHydrogen)

QualifiedValues

-ExtensionRange
*2.125-2.125


Entry 9 - fullUrl = urn:uuid:fd18b5d6-9fe1-91c4-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd18b5d6-9fe1-91c4-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd18b5d6-9fe1-91c4-2d06-47cb5b295e72

title: N

status: ACTIVE

code: Ion Analysis Nitrogen (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisNitrogen)

QualifiedValues

-ExtensionRange
*3.125-3.125


Entry 10 - fullUrl = urn:uuid:fd17b5d6-9fe1-91c5-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe1-91c5-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c5-2d06-47cb5b295e72

title: F

status: ACTIVE

code: Ion Analysis Flourine (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisFlourine)

QualifiedValues

-ExtensionRange
*4.125-4.125


Entry 11 - fullUrl = urn:uuid:fd17b5d6-9fe2-91c2-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9fe2-91c2-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72

title: NMR

status: ACTIVE

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)


Entry 12 - fullUrl = urn:uuid:fd17b5d6-9ff1-91c5-2d06-47cb5b295e72

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9ff1-91c5-2d06-47cb5b295e72"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e72

title: Structure (needed?)

status: ACTIVE

code: Chemical Structure (CodeSystem - Example Local Codes - Drug#Chemical Structure)


Entry 13 - fullUrl = urn:uuid:fd17b5d6-9ff1-91c5-2d06-47cb5b295e73

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9ff1-91c5-2d06-47cb5b295e73"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e73

title: Diffractogram (todo needed?)

status: ACTIVE

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


Entry 14 - fullUrl = urn:uuid:fd17b5d6-9ff1-91c5-2d06-47cb5b295e74

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9ff1-91c5-2d06-47cb5b295e74"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e74

status: ACTIVE

code: MolecularStructure (CodeSystem - Example Local Codes - Drug#MolecularStructure "Molecular Structure")


Entry 15 - fullUrl = urn:uuid:fd17b5d6-9ff1-91c5-2d06-47cb5b295e75

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "fd17b5d6-9ff1-91c5-2d06-47cb5b295e75"

url: http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e75

status: ACTIVE

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


Entry 16 - fullUrl = urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a33

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2a39-6609-1c01-4d197ea57a33"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72)

status: FINAL

code: Elemental Analysis Carbon (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisCarbon)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 83.75 %


Entry 17 - fullUrl = urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a34

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2a39-6609-1c01-4d197ea57a34"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e73)

status: FINAL

code: Elemental Analysis Hydrogen (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisHydrogen)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 2.75 %


Entry 18 - fullUrl = urn:uuid:9c56948c-2a39-6609-1c01-4d197ea57a35

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2a39-6609-1c01-4d197ea57a35"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e74)

status: FINAL

code: Elemental Analysis Nitrogen (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisNitrogen)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 5.55 %


Entry 19 - fullUrl = urn:uuid:9c56948c-3a39-6609-1c01-4d197ea57a35

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-3a39-6609-1c01-4d197ea57a35"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e75)

status: FINAL

code: Elemental Analysis Flourine (%) (CodeSystem - Example Local Codes - Drug#ElementalAnalysisFlourine)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 7.75 %


Entry 20 - fullUrl = urn:uuid:9c56948c-3a39-6609-1c01-4d197ea57a33

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-3a39-6609-1c01-4d197ea57a33"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c3-2d06-47cb5b295e72)

status: FINAL

code: Ion Analysis Carbon (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisCarbon)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 1.125

Components

-CodeValue[x]
*Ion Analysis Carbon - Mass Accuracy (CodeSystem - Example Local Codes - Drug#IonAnalysisCarbonMassAccuracy)0.001


Entry 21 - fullUrl = urn:uuid:9c56948c-4a39-6609-1c01-4d197ea57a34

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-4a39-6609-1c01-4d197ea57a34"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c4-2d06-47cb5b295e72)

status: FINAL

code: Ion Analysis Hydrogen (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisHydrogen)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 2.125

Components

-CodeValue[x]
*Ion Analysis Hydrogen - Mass Accuracy (CodeSystem - Example Local Codes - Drug#IonAnalysisHydrogenMassAccuracy)0.0055


Entry 22 - fullUrl = urn:uuid:9c56948c-5a39-6609-1c01-4d197ea57a35

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-5a39-6609-1c01-4d197ea57a35"

instantiates: See above (ObservationDefinition/fd18b5d6-9fe1-91c4-2d06-47cb5b295e72)

status: FINAL

code: Ion Analysis Nitrogen (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisNitrogen)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 3.125

Components

-CodeValue[x]
*Ion Analysis Nitrogen - Mass Accuracy (CodeSystem - Example Local Codes - Drug#IonAnalysisNitrogenMassAccuracy)0.003


Entry 23 - fullUrl = urn:uuid:9c56948c-6a39-6609-1c01-4d197ea57a35

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-6a39-6609-1c01-4d197ea57a35"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe1-91c5-2d06-47cb5b295e72)

status: FINAL

code: Ion Analysis Flourine (%) (CodeSystem - Example Local Codes - Drug#IonAnalysisFlourine)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: 4.125

Components

-CodeValue[x]
*Ion Analysis Flourine - Mass Accuracy (CodeSystem - Example Local Codes - Drug#IonAnalysisFlourineMassAccuracy)0.002


Entry 24 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d06-47cb5b295e72

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d06-47cb5b295e72"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 2.903 (dd, J=13.5, 9.6 Hz, 1H), 3.174 (dd, J=13.5, 4.4 Hz, 1H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: 40.35

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 3


Entry 25 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d06-47cb5b295e73

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d06-47cb5b295e73"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 4.558 (ddd, J=9.6, 8.0, 4.4 Hz, 1H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: 52.10

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 4


Entry 26 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d06-47cb5b295e74

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d06-47cb5b295e74"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 8.319 (d, J=8.0 Hz, 1H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: Absent because : unsupported

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 5


Entry 27 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d16-47cb5b295e74

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d16-47cb5b295e74"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: Absent because : unsupported

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: 169.72

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 6


Entry 28 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d26-47cb5b295e74

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d26-47cb5b295e74"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 3.241 (m, 2H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: 39.14

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 8


Entry 29 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d36-47cb5b295e74

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d36-47cb5b295e74"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 3.872 (bs, 1H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

value: 52.38

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 9


Entry 30 - fullUrl = urn:uuid:fd27b5d6-9fe2-91c2-2d46-47cb5b295e74

Resource Observation:

Generated Narrative: Observation

Resource Observation "fd27b5d6-9fe2-91c2-2d46-47cb5b295e74"

instantiates: See above (ObservationDefinition/fd17b5d6-9fe2-91c2-2d06-47cb5b295e72)

status: FINAL

code: NMR (CodeSystem - Example Local Codes - Drug#NMR "nmr")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

component

code: NMR-H (CodeSystem - Example Local Codes - Drug#NMR-H)

value: 7.8 to 8.6 (broad signal, 2H)

component

code: NMR-C (CodeSystem - Example Local Codes - Drug#NMR-C)

component

code: Structure Position (CodeSystem - Example Local Codes - Drug#POS)

value: 10


Entry 31 - fullUrl = urn:uuid:57a9af63-315d-1585-a261-0e337b289390

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

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

Profile: SubstanceDefinition - Component Substance Drug PQ

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

Names

-Name
*Stelbatolol


Entry 32 - fullUrl = urn:uuid:49d2f0c0-4b28-9271-8aaf-2996a8b9739c

Resource Organization:

Generated Narrative: Organization

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

Profile: Organization - Drug PQ

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

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


Entry 33 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

Generated Narrative: Organization

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

name: Testing Lab


Entry 34 - fullUrl = urn:uuid:fc078762-81c5-5656-9744-13c7ad1e595b

Resource Substance:

Generated Narrative: Substance

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

Profile: Substance - Drug PQ

Medication Manufacturing Batch

url

manufacturingDate

value: 2019-09-07

url

batchQuantity

value: 5.1 kg

url

batchUtilization

value: Development (NCI Thesaurus#C133991)

url

assignedManufacturer

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

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

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

Extension - Actual Yield PQ: 4.8 kg

identifier: SUB1Amgen

instance: true

Codes

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


Entry 35 - fullUrl = urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a33

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2b39-6609-1c01-4d197ea57a33"

instantiates: See above (ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e72)

status: FINAL

code: Chemical Structure (CodeSystem - Example Local Codes - Drug#Chemical Structure)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value:


Entry 36 - fullUrl = urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a34

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2b39-6609-1c01-4d197ea57a34"

instantiates: See above (ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e73)

status: FINAL

code: X-Ray Powder Diffractogram (CodeSystem - Example Local Codes - Drug#X-Ray Powder Diffractogram)

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value:


Entry 37 - fullUrl = urn:uuid:9c56948c-2b39-6619-1c01-4d197ea57a34

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2b39-6619-1c01-4d197ea57a34"

instantiates: See above (ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e74)

status: FINAL

code: MolecularStructure (CodeSystem - Example Local Codes - Drug#MolecularStructure "Molecular Structure")

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value:


Entry 38 - fullUrl = urn:uuid:9c56948c-2b39-6609-1c01-4d197ea57a35

Resource Observation:

Generated Narrative: Observation

Resource Observation "9c56948c-2b39-6609-1c01-4d197ea57a35"

instantiates: See above (ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e75)

status: FINAL

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

subject: See above (Substance/fc078762-81c5-5656-9744-13c7ad1e595b)

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

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

value: