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.5.2 Analytical Procedures.
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.
Determine the amount of Stelbat in each sample replicate as follows:
Where:
A SPL = Area of Stelbat in the sample
ANSR = Average normalized standard response factor of standard injections
DF = Overall sample dilution factor
N = Number of tablets in sample preparation
Determine the % label claim of the sample as follows:
Where:
LC = Label claim (mg/tablet) of tested sample