Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
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
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
| Version History |
|
Propose a change