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.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification.
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.
Test Procedure | Acceptance Criteria | Method Reference |
---|---|---|
Description | A white to brown powder | Visual inspection |
Identification | Conforms with reference | Identification by IR spectroscopy Identification by HPLC |
Assay | 98 % w/w - 102 % w/w | Assay by LC |
Drug Substance Related Organic impurities | ||
Impurity 1 | NMT 0.5 % w/w | Organic impurities by LC |
Impurity 2 | NMT 0.5 % w/w | |
Any individual unspecified impurity | NMT 0.10 % w/w | |
Total impurities | NMT 2.0 % w/w | |
Mutagenic impurities | NMT 50 ppm | Impurity 5 content by LC-MS |
Enantiomeric purity | NLT 99.6 % | Enantiomeric purity by LC |
Residual solvents | ||
Solvent 1 | NMT 0.1 % w/w | Residual solvents by headspace GC |
Solvent 2 | NMT 2.0 % w/w | |
Water Content | NMT 1.0 % w/w | USP Karl Fischer titration |
Particle size distribution | ||
D(v,0.9) | NMT 319 µm | Laser diffraction |
D(v,0.5) | NMT 145 µm | |
D(v,0.1) | NMT 20 µm |