Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.1 General Information, subsection 3.2.S.1.3 General Properties.
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.
| 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 |
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
Links: Table of Contents |
QA Report
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