If i have vildaglibtin and Metformin in combination in drug product.what is the AI vildaglibtin nitrosamine impurities?
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
