N-Nitrosamine
Highlights of Recent FDA Guidance on Nitrosamine Drug Substance
For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
The EMA and other Health authorities have published requirements (EMA/189634/2019) and Health Canada Letter for the API industry and the MAH for drug products to expand the scope of potential sources of nitrosamines beyond that of ICH M7. This requirement is based on the fact that, as the Industry and ... Read More
Best Practices to control N-Nitrosamine Impurities
N-Nitrosamine impurities are a major concern for pharmaceutical industry. Because it is regulatory requirement to control the nitrosamine impurities in human drugs. In this article we are sharing 10 best practices to control the nitrosamine impurites. Use high-quality raw materials: The quality of raw materials used in the manufacturing process ... Read More