Dr Prafulla S Chaudhari, VP – Technical, Nitika Pharmaceutical Specialities
Speaker in this video:
+ Dr Prafulla S Chaudhari, VP – Technical, Nitika Pharmaceutical Specialities
Topic: Control of nitrosomine impurities using low nirtrile excipients
Key Highlights:
[1] Nitrosamine mitigation requires a holistic approach. Raw materials, process conditions, moisture, pH, testing, and stability all matter.
[2] Nitrite levels vary widely between excipient suppliers and batches. Supplier qualification is now a critical part of risk management.
[3] Low-nitrite excipients can reduce nitrosamine risk by up to 10-fold. Reformulation and smarter excipient choices can have a major impact.
The post Dr Prafulla S Chaudhari, VP – Technical, Nitika Pharmaceutical Specialities appeared first on Express Pharma.
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