Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) 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: 3.2.P.5.1 Bundle

Document Content

32P51

Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7

Resource PlanDefinition:

Id: aa514363-d43f-4052-b44e-b67aa4d6dee7
Version: 1.0

ExampleSpecification

Title: Quality Specification for OXAZEPAM
Type:

system: http://terminology.hl7.org/CodeSystem/plan-definition-type

code: workflow-definition

display: Workflow Definition

system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

code: C134021

display: Drug Product

Subject:

reference: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9

Date: 2022-12-08
Actions:
Single Stage Spectrophotometry Identification:

Alternate
Single Stage Identity - Ferric Chloride:

Alternate
Single Stage Loss on Drying:
Single Stage Readily Carbonizable Sub:
Single Stage Residue on ignition (Ash):
Single Stage Substances insoluble in sodium carbonate TS:
Single Stage Impurities - Chloride (Cl):
Single Stage Impurities - Sulfate (SO4):
Single Stage Elemental Impurities - Limits:
Single Stage Limit of Free Salicylic Acid:
Single Stage Organic Volatile Impurities:
Single Stage Assay Dry Basis:
Dissolution - 30 minute:
Then:
Stage 1 :
Stage 2 :
Stage 3 :

Entry 3 - fullUrl = urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9

Resource MedicinalProductDefinition:

identifier: Example2BeadDrug

combinedPharmaceuticalDoseForm: CAPSULE

route: ORAL

name

productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg

type: Non-Proprietary

part

part: OXAZEPAM

type: scientific name

part

part: 30mg

type: OXAZEPAM

part

part: PROPRANOLOL HYDROCHLORIDE

type: scientific name

part

part: 60mg

type: PROPRANOLOL HYDROCHLORIDE

Entry 4 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

identifier: DUNS/143265222

name: Wunderwerke

Contacts

-Address
*Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478