STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, ...
The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients. Effective and safe APIs provide the necessary ...
Nitrosamine drug substance-related impurities (NDSRIs) are structurally similar to APIs, posing higher risks and requiring advanced detection methods. The Carcinogenic Potency Categorization Approach ...
The global recall of valsartan has now extended to Pfizer and to Japan, via Mylan and India. According to a translated copy of its announcement, Pfizer’s Tokyo-based Japanese subsidiary said it is ...
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