FDA 《Control of Nitrosamine Impurities in Human Drugs》中规定:For drug products with an MDD of less than 880 mg/day, a recommended limit for total nitrosamines of 0.03 ppm is not more than 26.5 ng/day and is considered acceptable.
如果按这个要求,不少药物里Nitrosamine Impurities(包含NDSRI)会超标,请问大家是怎么做的?

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The statement that you post is related to ‘total nitrosamines’, in the context of more than 1 nitrosamine impurity is found