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Many readers will be aware of the risk posed by nitrosamine impurities, as an ongoing pharmaceutical industry hot topic. In July 2021 ANVISA published their guidance for assessment and control of potentially carcinogenic nitrosamines in active pharmaceutical ingredients and drug products. To discuss this topic, we invited knowledgeable speakers from ANVISA, Industry - GSK and Libbs Farmacêutica - and Lhasa to give their perspectives on this topic. This article details the top 20 take away points from the workshop for quick and easy consumption - enjoy!

Are you getting the most out of Zeneth, Lhasa’s expert, knowledge-based in silico software for the prediction of forced degradation pathways of organic active pharmaceutical ingredients (APIs)? 

The ICH Q3B (Impurities in New Drug Products) guideline provides guidance on the qualification of impurities in new drug substances produced by chemical syntheses. This article discusses how Zeneth, Lhasa Limited’s expert decision support software for predicting the forced degradation of organic compounds, can help to satisfy ICH Q3B.