Global regulatory bodies have introduced a legal obligation for drug manufacturers to implement mitigation strategies that aim to minimize the risk of nitrosamine formation in drug products. The addition of antioxidants to drug formulations is a safe and viable, FDA-recommended mitigation strategy for inhibition of nitrosamine formation in drug products. Prevention of formation of potentially carcinogenic impurities is possible with commonly used ascorbic acid and alpha-tocopherol.
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Global regulatory bodies have introduced a legal obligation for drug manufacturers to implement mitigation strategies that aim to minimize the risk of nitrosamine formation in drug products. The addition of antioxidants to drug formulations is a safe and viable, FDA-recommended mitigation strategy for inhibition of nitrosamine formation in drug products. Prevention of formation of potentially carcinogenic impurities is possible with commonly used ascorbic acid and alpha-tocopherol.
