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.P.5 Control of Drug Product, subsection 3.2.P.5.1 Specification(s).
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 | ||
---|---|---|---|---|
Release | End of shelf life | |||
Description | An orange film-coated tablet, debossed with 175 on one side | As for release | Visual inspection | |
Identification | Consistent with the retention time and UV spectrum of the reference standard | As for release | ID by UHPLC | |
Assay | 95% to 105% of label claim | As for release | Assay by UHPLC | |
Degradation Products | ||||
Impurity 1 | NMT 0.2 % w/w | NMT 0.8 % w/w | Degradation products by UHPLC | |
Impurity 2 | NMT 0.3 % w/w | NMT 0.4 % w/w | ||
Impurity 3 | NMT 0.3 % w/w | NMT 0.4 % w/w | ||
Individual unspecified degradation products | NMT 0.2 % w/w | NMT 2.3 % w/w | ||
Total degradation products | NMT 1.4 % w/w | NMT 2.3 % w/w | ||
Dissolution | Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes | As for release | Apparatus 2 (paddles), UV measurement | |
Uniformity of dosage | Shall comply with the requirements of the harmonised USP/JP/Ph Eur | As for release | Weight variation | |
Microbiological | Shall comply with the requirements of the Ph Eur | As for release | Ph Eur | |
Water Content | NMT 1.0 % w/w | NMT 2.0 % w/w | USP <921> |