Example: Bundle – Substance Characterization - Pharmaceutical Quality (Industry) v1.0.0

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

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; Pharmaceutical Plan Type Codes#elucidation-of-structure "Elucidation of Structure")
status: ACTIVE
subject: See on this page: 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 (Structure Characterization Technique Codes#elemental-analyis)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e72
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e73
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c2-2d06-47cb5b295e74
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#ion-analyis)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c3-2d06-47cb5b295e72
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9fe1-91c4-2d06-47cb5b295e72
* Test () http://example-server.com/fhir/ObservationDefinition/fd18b5d6-9fe1-91c4-2d06-47cb5b295e72
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#structure)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#nmr)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#MolecularStructure)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#diffractogram)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/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 (Structure Characterization Technique Codes#absorption)
Actions
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/fd17b5d6-9ff1-91c5-2d06-47cb5b295e75

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

Resource DiagnosticReport:

Characterization Report
When For 2020-12
Report Details
Code Value When 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 (%) 1.125 2023-01-01 12:00:00+0000
Ion Analysis Hydrogen (%) 2.125 2023-01-01 12:00:00+0000
Ion Analysis Nitrogen (%) 3.125 2023-01-01 12:00:00+0000
Ion Analysis Flourine (%) 4.125 2023-01-01 12:00:00+0000
Chemical Structure No display for Attachment 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
NMR 2023-01-01 12:00:00+0000
Absorption No display for Attachment 2023-01-01 12:00:00+0000
MolecularStructure No display for Attachment 2023-01-01 12:00:00+0000
X-Ray Powder Diffractogram No display for Attachment 2023-01-01 12:00:00+0000
The samples have been assessed and the conclusion is...

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