Generated Narrative: Composition 0003c00b-bfc2-4775-8b1c-9f99d5cf1f39 Profile: eCTD Batch Formula identifier: BatchFormulaComposition status: Final type: m3.2.p.3.2 batch formula date: 2024-07-01 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
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 e875ef93-a730-4c44-bead-53663ae7f501 Profile: Basic Organization identifier: DUNS/147275722, FEI/6981397 name: East-West Manufacturing Contacts - Address * East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States
East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States
Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c Profile: Batch Formula Drug Product Identification identifier: Oxazepam-Propranolol-BatchFormula-Identification combinedPharmaceuticalDoseForm: LIQUID route: ORAL comprisedOf: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 name productName: ATOMOXETINE HYDROCHLORIDE 1mg type: Nonproprietary Name part part: ATOMOXETINE HYDROCHLORIDE type: scientific name part part: 1mg type: ATOMOXETINE HYDROCHLORIDE
Generated Narrative: ManufacturedItemDefinition 249ef22b-d521-4304-a388-6b9035f97b22 Profile: Drug Product Batch Formula identifier: Oxazepam-Propranolol-BatchFormula status: Active name: ATOMOXETINE HYDROCHLORIDE 1mg manufacturedDoseForm: Liquid manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 property type: Batch Quantity value: 50 liter (Details: UCUM codeL = 'L') property type: Batch Utilization value: Commercial property type: Batch Formula Additional Information value: Makes 50 Litres of product, accounting for losses from evaporation and spillage component type: Solution amount: 53.2 kilogram (Details: UCUM codekg = 'kg'), 100 percent (Details: UCUM code% = '%') constituent Product Batch Strength Textual Extension: 5% atomexetine hydrochloride solution amount: 25.42 gram (Details: UCUM codeg = 'g'), 0.0477 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 20.5 gram (Details: UCUM codeg = 'g'), 0.0385 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 5 gram (Details: UCUM codeg = 'g'), 0.0094 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 2.27 kilogram (Details: UCUM codekg = 'kg'), 4.2652 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 150 gram (Details: UCUM codeg = 'g'), 0.2818 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 constituent amount: 50.75 kilogram (Details: UCUM codekg = 'kg'), 95.3572 percent (Details: UCUM code% = '%') HasIngredients - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 Properties - Type Value[x] * Product Part Identifier solution
Makes 50 Litres of product, accounting for losses from evaporation and spillage
Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77 Profile: Drug Product Batch Formula Ingredient identifier: AtomexetineHydrochlorideBFIngredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 25.42 gram (Details: UCUM codeg = 'g') strength concentration: 0.0477 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 Codes - Code * 57WVB6I2W0 Names - Name Type Preferred * ATOMOXETINE HYDROCHLORIDE GSRS Preferred Term true
Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2 Profile: Drug Product Batch Formula Ingredient identifier: GlacialAceticAcidBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 20.5 gram (Details: UCUM codeg = 'g') strength concentration: 0.0385 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1 Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * Q40Q9N063P Names - Name Type Preferred * ACETIC ACID GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76 Profile: Drug Product Batch Formula Ingredient identifier: AnhydrousSodiumAcetateBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 5 gram (Details: UCUM codeg = 'g') strength concentration: 0.0094 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * NVG71ZZ7P0 Names - Name Type Preferred * SODIUM ACETATE ANHYDROUS GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552 Profile: Drug Product Batch Formula Ingredient identifier: MannitolBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 2.27 kilogram (Details: UCUM codekg = 'kg') strength concentration: 4.2652 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 3OWL53L36A Names - Name Type Preferred * MANNITOL GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269 Profile: Drug Product Batch Formula Ingredient identifier: MetacresolBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 150 gram (Details: UCUM codeg = 'g') strength concentration: 0.2818 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * GGO4Y809LO Names - Name Type Preferred * METACRESOL GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557 Profile: Drug Product Batch Formula Ingredient identifier: WaterBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 strength concentration: 50.75 kilogram (Details: UCUM codekg = 'kg') strength concentration: 95.3572 percent (Details: UCUM code% = '%')
Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical