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

Entry 1 - fullUrl = urn:uuid:1g1g1g1g-1g1g-1g1g-1g1g-1g1g1g1g1g1g

Resource MedicinalProductDefinition:

Language: en

Profile: MedicinalProductDefinition - Drug Product PQ

identifier: http://example.org/identifiers/product/PROD-12345

combinedPharmaceuticalDoseForm: Tablet

route: Oral use

Names

-	ProductName	Type
*	Stelbatolol 10mg Tablets	Invented Name

Entry 2 - fullUrl = urn:uuid:2g2g2g2g-2g2g-2g2g-2g2g-2g2g2g2g2g2g

Resource SubstanceDefinition:

Language: en

Profile: SubstanceDefinition - Component Substance Drug PQ

status: Active

manufacturer: Organization AAA Molybdenum Products, Inc.

Names

-	Name
*	Stelbatolol Hydrochloride

Entry 3 - fullUrl = urn:uuid:3g3g3g3g-3g3g-3g3g-3g3g-3g3g3g3g3g3g

Resource Medication:

Language: en

Profile: Medication - Batch Information Drug PQ

code:

batch

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-06

url

batchQuantity

value: 100100 tablets

url

batchUtilization

value: Production

url

assignedManufacturer

value: Organization AAA Molybdenum Products, Inc.

closureSystemDescription: 100 cc HDPE Bottle 2 g desiccant

url

container

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Designation PQ: Maximum

Extension - Batch Number of Vials PQ: 3

Extension - Batch Substance Batch PQ: Substance

Extension - Packaging Date PQ: 2020-08

Extension - Packaging Site PQ: Organization AAA Molybdenum Products, Inc.

Extension - Actual Yield PQ: 4.81 kg

Extension - Actual Yield Unfiltered PQ: 4.91 kg

Extension Target Fill Weight PQ: 30 g

lotNumber: 33445

Entry 4 - fullUrl = urn:uuid:4g4g4g4g-4g4g-4g4g-4g4g-4g4g4g4g4g4g

Resource DiagnosticReport:

Language: en

Profile: DiagnosticReport - Analysis Drug PQ

Stability Study Report - 18 months

When For	2020-12
Performer	Organization AAA Molybdenum Products, Inc.
Identifier	https://eudract.europa.eu/example/identifier/ABC1234

Report Details

Code	Value	Flags	When For
Test Components - Long-term 25C etc - Initial (XYZ)		Final	2023-01-01 12:00:00+0000

The samples have been assessed for initial period; no shelf life determined.

Entry 5 - fullUrl = urn:uuid:5g5g5g5g-5g5g-5g5g-5g5g-5g5g5g5g5g5g

Resource Observation:

Language: en

Profile: Observation - Test Result Drug PQ

status: Final

code: Degradation Products

subject: Medication

effective: 2023-01-01 12:00:00+0000

performer: Organization AAA Molybdenum Products, Inc.

value: 0.801 % w/w (Details: UCUM code% = '%')

Components

-	Code	Value[x]
*	Impurity	Total Degradation Impurities

Entry 6 - fullUrl = urn:uuid:6g6g6g6g-6g6g-6g6g-6g6g-6g6g6g6g6g6g

Resource Organization:

Language: en

Profile: Organization - Drug PQ

identifier: FDA Establishment Identifier/3003040516

active: true

type: Drug Substance Manufacture

name: AAA Molybdenum Products, Inc.

Contacts

-	Address
*	7233 W 116th Pl Ste C Broomfield Colorado 80020 USA