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
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 the authorities are gathering more…
The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation to prevent these impurities and degradants. Impurity and degradant structure elucidation…
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 plays a crucial role in…