Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.6 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070
identifier: ASPIRIN-ACETAMINOPHEN
status: Active
name: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets
manufacturedDoseForm: Tablet
manufacturer: Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000
property
type: Batch Quantity
value: 2000 1* (Details: UCUM code1 = '1')
property
type: Batch Utilization
value: Development
property
type: Product Part Additional Information
value:
Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation
component
type: Layer
amount: 925.97 gram (Details: UCUM codeg = 'g'), 38.55 percent (Details: UCUM code% = '%')
constituent
amount: 400 gram (Details: UCUM codeg = 'g'), 43.1 percent (Details: UCUM code% = '%')
location: Purple Layer
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent
amount: 524.01 gram (Details: UCUM codeg = 'g'), 56.59 percent (Details: UCUM code% = '%')
location: Purple Layer
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent
amount: 203.71 gram (Details: UCUM codeg = 'g'), 22 percent (Details: UCUM code% = '%')
location: Purple Layer
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent
amount: 305.57 gram (Details: UCUM codeg = 'g'), 33 percent (Details: UCUM code% = '%')
location: Purple Layer
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Properties
Type Value[x] Product Part Identifier Purple Layer
component
type: Layer
amount: 1476.03 gram (Details: UCUM codeg = 'g'), 61.45 percent (Details: UCUM code% = '%')
constituent
amount: 600.01 gram (Details: UCUM codeg = 'g'), 40.65 percent (Details: UCUM code% = '%')
location: Example1Drug_LayerB
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent
amount: 876.02 gram (Details: UCUM codeg = 'g'), 59.35 percent (Details: UCUM code% = '%')
location: Example1Drug_LayerB
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent
amount: 369.01 gram (Details: UCUM codeg = 'g'), 25 percent (Details: UCUM code% = '%')
location: Example1Drug_LayerB
HasIngredients
Reference Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Properties
Type Value[x] Product Part Identifier Example1Drug_LayerB
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.1.6 based on FHIR 5.0.0. Generated 2024-09-22
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