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A talk from the PerkinElmer Chemicals Summit – Pharmaceutical Chemicals Symposium
MSN Group is a leading pharmaceutical company with the mission to contribute to improved quality of life through sustained efforts in developing and manufacturing safe, innovative and affordable pharmaceuticals for the alleviation of life-threatening diseases. MSN Group has 9 API and 5 finished dosage facilities (including Oncology), an integrated R&D center, and over 250 customers across 65 countries around the globe.
In this presentation by Dr. Vijayavitthal T. Mathad, Sr. Vice President of R&D and PSDL at MSN Laboratories, India reviews residual solvents analysis for USP 467 compliance and its associated regulatory directives and challenges. Topics discussed are quality attributes of drug substance APIs, classifications, risk assessments and testing procedures for residual solvent impurities, the analytical techniques involved, as well as the challenges and business impacts of non-compliance.
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