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