DMF in API, specification limit in formulation

Hi,

I recommend checking out the following link for better understanding of the calculation:

Define MDD to calculate limit

Moreover, if there’s any known Nitrosamine impurity, it should be calculated as AI ng per day / MDD mg per day.

Eexample: NDMA= 96/500= 0.192 or 0.2 ppm. This limit also applies to DS and DP.

You may raise your question to DS team how they calculate NDMA limit is 880 ppm ?

Regards,
Dr. Dinkar

1 Like