US FDA Suggests Adding Antioxidants To Drug Formulations To Mitigate Nitrosamine Risks
Agency recommends “mitigation strategies” also including designing formulations that incorporate excipients such as sodium carbonate which modify the micro-environment to neutral or basic pH.
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The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
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