Pharmaceutical Quality (Industry)
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This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Identification: CMC synthetic data rendering - drug substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.3 Characterisation, subsection 3.2.S.3.1 Elucidation of Structure and Other Characteristics.

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.

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Bundle [documentation R4 R5 R6]
id: bundle-drug-substance-general-properties-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-characterization-pq
Type: collection
Substance - Stelbatolol

Drug Substance General Properties


Physical and Chemical Properties Results
Appearance white to slightly yellow powder
Solubilities according to PhEur 1.4
  Solubility purified water (PhEur) freely soluble (23 mg/mL to 27 mg/mL)
  Solubility Acetone (PhEur) slightly soluble (2 mg/mL to 3 mg/mL)
  Solubility Ethanol (PhEur) soluble (15 mg/mL to 17 mg/mL)
Solubilities at saturation in aqueous medium after 2 hours
  Purified Water ~21 mg/mL
  Glucose (5%) ~2.5 mg/mL
Solubility as a function of pH in USP buffers
  pH=1.2 22 mg/mL
  pH=4.5 29 mg/mL
Hygroscopy Hygroscopic
Stereochemistry One asymmetric center and one axis of chirality; (S,M) - enantiomer

[documentation R4 R5 R6]
id: substancedefinition-substance-drug-pq-ex1
fullUrl: urn:uuid:57a9af63-315d-1585-a261-0e337b289390
Name: Stelbatolol
Property
Type: Appearance [appearance] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: white to slightly yellow powder
Property
Type: Solubility purified water (PhEur) [solubility-water-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: Freely soluble [sol-free] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-solubility-local-pq) - Text: freely soluble
Property
Type: Solubility purified water (PhEur) [solubility-water-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: from 23 mg/mL to 27 mg/mL
Property
Type: Solubility Acetone (PhEur) [solubility-acetone-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: Slightly soluble [sol-slight] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-solubility-local-pq) - Text: slightly soluble
Property
Type: Solubility acetone (PhEur) [solubility-acetone-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: from 2 mg/mL to 3 mg/mL
Property
Type: Solubility Ethanol (PhEur) [solubility-ethanol-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: Soluble [sol-soluble] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-solubility-local-pq) - Text: soluble
Property
Type: Solubility ethanol (PhEur) [solubility-ethanol-pheur] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: from 15 mg/mL to 17 mg/mL
Property
Type: Solubility at saturation in Purifed Water after 2 hours (approx) [solubility-aq-water-2h-approx] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: 21 mg/mL
Property
Type: Solubility at saturation in Glucose (5%) after 2 hours (approx) [solubility-aq-glucose-2h-approx] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq) - Text: Glucose solution (5%)
Value: 2.5 mg/mL
Property
Type: Solubility as a function of pH in USP buffers [solubility-usp-ph] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter: pH [pH] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter Value: 1.2
Value: 22 mg/mL
Property
Type: Solubility as a function of pH in USP buffers [solubility-usp-ph] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter: pH [pH] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter Value: 4.5
Value: 29 mg/mL
Property
Type: pH in aqueous solution [ph-aq] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter: Concentration [concentration] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter Value: 10 mg/ml
Parameter: Temperature [temperature] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Parameter Value: 25 °C
Value: from 6.7 to 6.8
Property
Type: Hygroscopy [hygroscopy] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq)
Value: Hygroscopic [hygroscopy-hygroscopic] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-substance-property-local-pq) - Text: Hygroscopic
Structure
Stereochemistry: One asymmetric center and one axis of chirality; (S,M) - enantiomer