Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
Bundle bundle-drug-product-composition-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Stelbatalol is formulated as an immediate-release, oral, solid dosage form in strengths of 20 mg of the free base equivalent. The 20 mg strength is presented as an orange, round, film coated tablet, debossed with '175' on one side.
Names
ProductName Type Stalbatolol Proprietary (Product Name Type - example#Proprietary)
Entry 2 - fullUrl = urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "88a068e2-1d97-337b-3b9c-4b3f14bc3923"
Profile: PackagedProductDefinition - Drug PQ
packageFor: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
description: The commercial primary pack is a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) screw cap. Inside the bottle is a desiccant, containing silica gel. Induction seal membranes provide additional tamper evidence. For further details of the packaging components, see ‘P.7 Container Closure System for Drug Product’.
Entry 3 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a65"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Active (Ingredient Role#100000072072)
substance
Codes
Reference See on this page: SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380474: Stelbatolol strength
presentation: 15.2 mg/1 tablet
strength
concentration: 97.9 % w/w
Entry 4 - fullUrl = urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a65
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d3-80f9-0cfb-70a1-5a6572e73a65"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Excipient (Ingredient Role#100000072082)
function: Diluent (Ingredient Function Codes#diluent)
substance
Codes
Reference See on this page: SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380475: Mannitol strength
presentation: 145.0 mg/1 tablet
strength
concentration: 1 % w/w
Entry 5 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-71a1-5a6572e73a65
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d2-80f9-0cfb-71a1-5a6572e73a65"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Excipient (Ingredient Role#100000072082)
function: Disintegrant (Ingredient Function Codes#disintegrant)
substance
Codes
Reference See on this page: SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380476: Maize starch strength
presentation: 13.8 mg/1 tablet
strength
concentration: 0.5 % w/w
Entry 6 - fullUrl = urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a66
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d2-80f9-0cfb-70a1-5a6572e73a66"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Excipient (Ingredient Role#100000072082)
function: Disintegrant (Ingredient Function Codes#disintegrant)
substance
Codes
Reference See on this page: SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380477: Calcium carboxymethylcellulose strength
presentation: 4.0 mg/1 tablet
strength
concentration: 0.25 % w/w
Entry 7 - fullUrl = urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a66
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "b89ed9d3-80f9-0cfb-70a1-5a6572e73a66"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Excipient (Ingredient Role#100000072082)
function: Lubricant (Ingredient Function Codes#lubricant)
substance
Codes
Reference See on this page: SubstanceDefinition/4cf2cbba-33e6-1124-9bf2-1c6756380478: Magnesium stearate strength
presentation: 2.0 mg/1 tablet
strength
concentration: 0.35 % w/w
Entry 8 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380474"
grade: In-house (Package Grade Codes#in-house)
Names
Name Stelbatolol
Entry 9 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380475"
grade: NF / Ph Eur (Package Grade Codes#NF-PH-Eur)
Names
Name Mannitol
Entry 10 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380476
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380476"
grade: NF / Ph Eur (Package Grade Codes#NF-PH-Eur)
Names
Name Maize starch
Entry 11 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380477
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380477"
grade: NF / Ph Eur (Package Grade Codes#NF-PH-Eur)
Names
Name Calcium carboxymethylcellulose
Entry 12 - fullUrl = urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380478
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "4cf2cbba-33e6-1124-9bf2-1c6756380478"
grade: NF / Ph Eur (Package Grade Codes#NF-PH-Eur)
Names
Name Magnesium stearate