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The Presence of Nitrosamines, Azido and Other Mutagenic Impurities Might Adversely Impact the Safety, Quality and Efficacy of Drug Substances and Drug Products. The Estimation of The Impurity Profiles and Their Control and Monitoring Became an Inevitable Part of The Successful Development and Production of New Drugs.
To Comply with Increased Regulatory Requirements and Avoid Expensive Recalls, The Proactive Identification of Impurities Should Be Established at Every Stage of Drug Development.
In the Following Seminar Waters Team Will Share Latest Regulatory Requirements for Nitrosamines Impurity, Risk Assessment Strategy, Latest Methods for Detecting and Measuring Nitrosamine Impurities, Azido and Other Product/Process Related Impurities for Drug Product and Drug Substances.