Generated Narrative: Composition c00b0003-c2bf-7547-8b1c-f1f399f99d5c Profile: eCTD Batch Formula identifier: BatchFormulaComposition2layer status: Final type: m3.2.p.3.2 batch formula date: 2024-08-01 12:34:56+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: Batch formula example two layer tablet
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
Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7 Profile: Basic Organization identifier: DUNS/143265222 name: Large Life Contacts - Address * 123 Broad Way, New York, NY, United States
123 Broad Way, New York, NY, United States
Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c Profile: Batch Formula Drug Product Identification identifier: ASPIRIN-ACETAMINOPHEN-Identification combinedPharmaceuticalDoseForm: TABLET, MULTILAYER route: ORAL comprisedOf: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 name productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg type: Nonproprietary Name part part: ASPIRIN type: scientific name part part: 200mg type: ASPIRIN part part: ACETAMINOPHEN type: scientific name part part: 300mg type: ACETAMINOPHEN
Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070 Profile: Drug Product Batch Formula identifier: ASPIRIN-ACETAMINOPHEN status: Active name: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets manufacturedDoseForm: Tablet manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 property type: Batch Quantity value: 2000 tablets (Details: UCUM code{tbl} = '{tbl}') property type: Batch Utilization value: Development property type: Batch Formula 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 Overage Extension proportionDecimal: 0.02 justification: Evaporation amount: 311.68 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
ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets
Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation
Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562 Profile: Drug Product Batch Formula Ingredient identifier: Asprin - Ingredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 400 gram (Details: UCUM codeg = 'g') strength concentration: 10.4 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f Profile: Drug Product Batch Formula Ingredient identifier: AcetaminophenIngredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 600 gram (Details: UCUM codeg = 'g') strength concentration: 25 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08 Profile: Drug Product Batch Formula Ingredient identifier: MaizeStarchIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 1400.03 gram (Details: UCUM codeg = 'g') strength concentration: 58.28 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f Profile: Drug Product Batch Formula Ingredient identifier: GrapeskinIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 203.71 gram (Details: UCUM codeg = 'g') strength concentration: 8.48 percent (Details: UCUM code% = '%')
Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604 Profile: Drug Product Batch Formula Ingredient identifier: WaterBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 50.75 kilogram (Details: UCUM codekg = 'kg') strength concentration: 95.3572 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * R16CO5Y76E Names - Name Type Preferred * ASPIRIN GSRS Preferred Term true
Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * 362O9ITL9D Names - Name Type Preferred * ACETAMINOPHEN GSRS Preferred Term true
Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e Profile: Excipient Drug Substance classification: Mixture grade: Company Standard Codes - Code * O8232NY3SJ Names - Name Type Preferred * STARCH, CORN GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4 Profile: Excipient Drug Substance classification: Mixture grade: BP Codes - Code * 3GOV20705G Names - Name Type Preferred * WINE GRAPE GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant vitis vinifera fruit skin Italy
Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6 Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b Profile: Basic Organization identifier: DUNS/143265222 name: Vandechemie Contacts - Address * Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium