How to set Acceptance criteria for nitrosamines impurities in FDC-FPPs

Limits of Nitrosamines
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Continuing the discussion from N-nitroso-Impurity C in Metamizol Drug product:

How to set Acceptance criteria for nitrosamines impurities (N- Nitrosodimethylamine (NDMA) and N-Nitrosamine Sitagliptin (Nitroso-STG-19) in FDC-FPPs (Metformin Hydrochloride, MDD=3000 mg/day and Sitagliptin , MDD= 100 mg/day ), maximum daily dose will be based for individual API or API that represents the worst case MDD will be applied

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hi.
please refer to Nitrosamine Calculation in Sita + Met Tablets
i think it would be helpful for your case too

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