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Controlling Nitrosamine impurities: Questions & Answers

The nitrosamines may occur in very small quantities in some drugs but they are a potential carcinogen. That’s why Nitrosamine impurities have been a source of concern in the pharmaceutical industry. On 31 January 2022 The European Medicines Agency (EMA) announced a revised question and answer guidance explaining how marketing authorization...

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MOST IMPORTANT FACTORS FOR PHARMACEUTICAL IMPURITIES / REFERENCE STANDARDS

It is interesting to discuss the most important factors for the Pharmaceutical impurities / Reference standards in detail. Because these are the critical factors for the quality of various pharmaceutical products. Pharmaceutical impurities / Reference standards are used as primary standards or secondary standards for the quality control of active...

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