Satyanarayana.B Satya

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Nitrosamine impurities evaluation, shall we consider API Structure in evaluation?

Nitrosamine impurities evaluation, shall we consider API Structure in evaluation. 1. API structure contains Amines, in this case shall i considered API structure ? 2. API Structure contains...

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How many batches are recommended in validation of process?

Hi, Any body having process validation guidance from Conformity batches to Commercial batches. During validation of new process, how many batches are recommended.

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