3.2.P.3.2 Bundle for liquid - Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA v2.0.0

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. For a full list of available versions, see the Directory of published versions

Example Bundle: 3.2.P.3.2 Bundle for liquid

Document Details

Profile: CMC eCTD 32P32 Document

Final Document at 2024-07-01 12:34:56+0000 by Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 for

Document Content

Batch Formula

Additional Resources Included in Document

Entry 2 - fullUrl = urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a

Resource Organization:

Profile: Basic Organization
identifier: DUNS/143265222
name: Wunderwerke
Contacts
- Address
* Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478

Entry 3 - fullUrl = urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501

Resource Organization:

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

Entry 4 - fullUrl = urn:uuid:d0d2df25-5cfa-4417-b8d1-b8147957f53c

Resource MedicinalProductDefinition:

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

Entry 5 - fullUrl = urn:uuid:249ef22b-d521-4304-a388-6b9035f97b22

Resource ManufacturedItemDefinition:

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

Entry 6 - fullUrl = urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77

Resource Ingredient:

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% = '%')

Entry 7 - fullUrl = urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058

Resource SubstanceDefinition:

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

Entry 8 - fullUrl = urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2

Resource Ingredient:

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% = '%')

Entry 9 - fullUrl = urn:uuid:45942749-64db-4f91-88c3-51adb680fed1

Resource SubstanceDefinition:

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

Entry 10 - fullUrl = urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76

Resource Ingredient:

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% = '%')

Entry 11 - fullUrl = urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff

Resource SubstanceDefinition:

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

Entry 12 - fullUrl = urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552

Resource Ingredient:

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% = '%')

Entry 13 - fullUrl = urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da

Resource SubstanceDefinition:

Profile: Excipient Drug Substance
classification: Chemical
grade: USP-NF
Codes
- Code
* 3OWL53L36A
Names
- Name Type Preferred
* MANNITOL GSRS Preferred Term true
SourceMaterials
- Type
* Chemical

Entry 14 - fullUrl = urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269

Resource Ingredient:

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% = '%')

Entry 15 - fullUrl = urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e

Resource SubstanceDefinition:

Profile: Excipient Drug Substance
classification: Chemical
grade: USP-NF
Codes
- Code
* GGO4Y809LO
Names
- Name Type Preferred
* METACRESOL GSRS Preferred Term true
SourceMaterials
- Type
* Chemical

Entry 16 - fullUrl = urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557

Resource Ingredient:

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% = '%')

Entry 17 - fullUrl = urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b

Resource SubstanceDefinition:

Profile: Excipient Drug Substance
classification: Chemical
grade: USP-NF
Codes
- Code
* 059QF0KO0R
Names
- Name Type Preferred
* WATER GSRS Preferred Term true
SourceMaterials
- Type
* Chemical

IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-07-08
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