Pharmaceutical Testing Service
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 Products & Product Related Impurities as in ICH Topics Q3A(R)/Q3B- Analysis of Residual Solvents as required by ICH Topic Q3C- Extractables and Leachables rom 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 Volatile Organic Carbons (VOCs) and airborne product residues in manufacturing facilitiesAnalysis can be performed to GLP/cGMP if required.