Bundle bundle-drug-product-pq-ex1 of type collection

Entry 1 - fullUrl = urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5

Resource Composition:

Generated Narrative: Composition

Resource Composition "a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"

status: FINAL

type: Product Note - Drug Components ()

date: 2023-10-01

author: See above (Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d)

title: 3.2.P.2.1.1 - Components of the Drug Product

Entry 2 - fullUrl = urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource Composition:

Generated Narrative: Composition

Resource Composition "a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"

Profile: Composition - Drug PQ

status: FINAL

type: Product Note - Formulation Development ()

date: 2023-10-01

author: See above (Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d)

title: 3.2.P.2.2.1 - Formulation Development

Entry 3 - fullUrl = urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5

Resource Composition:

Generated Narrative: Composition

Resource Composition "a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"

Profile: Composition - Drug PQ

status: FINAL

type: Product Note - Summary for Risk of Impurities ()

date: 2023-10-01

author: See above (Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d)

title: 3.2.P.2.2.4 - Summary for Risk of Impurities

Entry 4 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition

Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"

comprisedOf: See above (ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44)

Names

-	ProductName
*	Stalbatolol

characteristic

type: Physicochemical properties (CodeSystem - Example Local Codes - Drug#physicochemical)

value: Product properties with cross reference to other dossier sections as 3.2.P.5.1 Consider parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity. Any properties which are not included in the product specification, with explanation of parameter control and relevant studies. If applicable refer to relevant compendia monograph ()

characteristic

type: pH (CodeSystem - Example Local Codes - Drug#pH)

value: 7.0

characteristic

type: Ionic Strength (CodeSystem - Example Local Codes - Drug#ionic-strength)

value: 23 mg/mL

Entry 5 - fullUrl = urn:uuid:1531c777-50c3-047d-2798-de3d001d2c44

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition

Resource ManufacturedItemDefinition "1531c777-50c3-047d-2798-de3d001d2c44"

Profile: ManufacturedItemDefinition - Drug PQ

status: ACTIVE

name: Stelbatolol 5mg tablet

manufacturedDoseForm: ()

property

type: Overage by mass (%) (CodeSystem - Manufactured Item Property#overage-by-mass)

value: 5 %

property

type: Overage reason (CodeSystem - Manufactured Item Property#overage-reason)

value: Overage is necessary because... ()

Entry 6 - fullUrl = urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d

Resource Organization:

Generated Narrative: Organization

Resource Organization "9fe98cfa-9246-8313-0fc5-d15e613b5d6d"

name: AAA Molybdenum Products, Inc.