LoQ of 0.03 ppm

[Naiffer_Host]

@Tharcilla we have addressed that question in this post…

Define MDD to calculate limit

Hi everyone, If Maximum Daily dose for Rosuvastatin is 40mg then for a Nitrosamine with AI=26.5ng/day the limit is 26.5ng per day/40mg = 0.66ppm. What is the limit of this nitrosamine in the Drug Product? Is it still 0.66ppm ? or Since the API is not the only possible source of nitrosamine, the limit should be AI / MDD of Drug Product and not of API MDD? Meaning 26.5ng per day / 360mg = 0.074ppm (where 360mg is the weight of a tablet of Rosuvastatin 40mg, i.e. the MDD of the Drug Product in…