If i have vildaglibtin and Metformin in combination in drug product.what is the AI vildaglibtin nitrosamine impurities?
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The calculation of AI when more than one nitrosamine is identified in the product - if there is N-Nitroso Vildagliptin along with NDMA which may form from the DMA impurity of Metformin, this is specified in the guidelines, e.g., Q&A 10 in
At that case w have at least two to
Even more carcinogenic substances with unpredictable carcinogenic potency when acting together …, which could contribute to cancer development and progression independent / or dependent on their not disclosed officially carcinogenic concentrations 