M-Scan provides a range of analytical services for companies manufacturing small molecule pharmaceutical products including:
- Development of combined chromatography and mass spectrometric techniques for the analysis of the product as required in ICH Topic Q6A
- Confirmation of identity of the API
- Purity analysis on feedstocks
- Analysis of Process & Product Related Impurities as in ICH Topics Q3A(R)/Q3B
- Analysis of Residual Solvents as required by ICH Topic Q3C
- Extractables and leachables from packaging/containers and closure systems
- Validation of Cleaning Protocols to CFR Title 21 Part 211.67
- Analysis of residual detergents used in cleaning
- Analysis of VOCs and airborne product residues in manufacturing facilities
Analysis can be performed to GLP/cGMP if required.
M-Scan Brochure: Biotechnology and Pharmaceutical Analysis (8pp.)