Pharmaceutical Quality (Industry)
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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

Composition: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.1 Description and Composition of the Drug Product, subsection 3.2.P.6 Reference Standards or Materials.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-drug-product-composition-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-composition-pq
Type: collection
Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stalbatolol
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)
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.

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.

Composition

Qualitative and Quantitative Composition


Components Quantity (mg per unit) Percentage (% w/w) Function Quality Standard
Stelbatolol 15.2 97.9% Active In-house
Mannitol 145.0 1% Diluent NF / Ph Eur
Maize starch 13.8 0.5% Disintegrant NF / Ph Eur
Calcium carboxymethylcellulose 4.0 0.25% Disintegrant NF / Ph Eur
Magnesium stearate 2.0 0.35% Lubricant NF / Ph Eur
Nominal tablet Weight 180.0

Container closure system

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’.

↸arrow indicates that this PackagedProductDefinition resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via PackagedProductDefinition.packageFor
Package [documentation R4 R5 R6]
id: packagedproductdefinition-dxpq-ex1
fullUrl: urn:uuid:88a068e2-1d97-337b-3b9c-4b3f14bc3923
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq
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’.
Ingredient - Active [100000072072] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: ingredient1
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65
Status: active
Role: Active [100000072072] (http://hl7.org/fhir/ingredient-role)
Substance
Found a parent (Ingredient/code, id: ingredient1 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a65)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380474
Name: Stelbatolol
Grade: In-house [in-house] (http://terminology.hl7.org/CodeSystem/package-grade)
Display: Stelbatolol
Strength
Presentation Strength: 15.2 mg per 1 tablet
Strength
Concentration Quantity: 97.9% w/w
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient1
fullUrl: urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a65
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Function: Diluent [diluent] (http://terminology.hl7.org/CodeSystem/ingredient-function)
Substance
Found a parent (Ingredient/code, id: excipient1 fullUrl: urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a65)
which is linked to this by resource.id
Substance - Mannitol [documentation R4 R5 R6]
id: sd-excipient1
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380475
Name: Mannitol
Grade: NF / Ph Eur [NF-PH-Eur] (http://terminology.hl7.org/CodeSystem/package-grade)
Display: Mannitol
Strength
Presentation Strength: 145.0 mg per 1 tablet
Strength
Concentration Quantity: 1% w/w
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient2
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-71a1-5a6572e73a65
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Function: Disintegrant [disintegrant] (http://terminology.hl7.org/CodeSystem/ingredient-function)
Substance
Found a parent (Ingredient/code, id: excipient2 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-71a1-5a6572e73a65)
which is linked to this by resource.id
Substance - Maize starch [documentation R4 R5 R6]
id: sd-excipient2
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380476
Name: Maize starch
Grade: NF / Ph Eur [NF-PH-Eur] (http://terminology.hl7.org/CodeSystem/package-grade)
Display: Maize starch
Strength
Presentation Strength: 13.8 mg per 1 tablet
Strength
Concentration Quantity: 0.5% w/w
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient3
fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a66
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Function: Disintegrant [disintegrant] (http://terminology.hl7.org/CodeSystem/ingredient-function)
Substance
Found a parent (Ingredient/code, id: excipient3 fullUrl: urn:uuid:b89ed9d2-80f9-0cfb-70a1-5a6572e73a66)
which is linked to this by resource.id
Substance - Calcium carboxymethylcellulose [documentation R4 R5 R6]
id: sd-excipient3
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380477
Name: Calcium carboxymethylcellulose
Grade: NF / Ph Eur [NF-PH-Eur] (http://terminology.hl7.org/CodeSystem/package-grade)
Display: Calcium carboxymethylcellulose
Strength
Presentation Strength: 4.0 mg per 1 tablet
Strength
Concentration Quantity: 0.25% w/w
Ingredient - Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
[documentation R4 R5 R6]
id: excipient4
fullUrl: urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a66
Status: active
Role: Excipient [100000072082] (http://hl7.org/fhir/ingredient-role)
Function: Lubricant [lubricant] (http://terminology.hl7.org/CodeSystem/ingredient-function)
Substance
Found a parent (Ingredient/code, id: excipient4 fullUrl: urn:uuid:b89ed9d3-80f9-0cfb-70a1-5a6572e73a66)
which is linked to this by resource.id
Substance - Magnesium stearate [documentation R4 R5 R6]
id: sd-excipient4
fullUrl: urn:uuid:4cf2cbba-33e6-1124-9bf2-1c6756380478
Name: Magnesium stearate
Grade: NF / Ph Eur [NF-PH-Eur] (http://terminology.hl7.org/CodeSystem/package-grade)
Display: Magnesium stearate
Strength
Presentation Strength: 2.0 mg per 1 tablet
Strength
Concentration Quantity: 0.35% w/w