Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2 Profile: eCTD Specification identifier: ExampleSpecification status: Final type: m3.2.p.5.1 specification(s) date: 2023-12-15 22:33:13+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: Quality Specification for an example Drug Product
Quality Specification for an example Drug Product
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 :
Maxima only at the same wavelengths compared to reference standard
Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution
Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q - 15%
Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q - 15%, no unit is less than Q - 25%
Substances insoluble in sodium carbonate TS
Impurities/Degradation Products/Related Substances
Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9 Profile: Drug Product Handle 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
OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg
Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a Profile: Basic Organization identifier: DUNS/143265222 name: Wunderwerke Contacts - Address * Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478