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 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 ...

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types. FDA lowered its estimate of the impact on patients of nitrosamine ...

In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products. To ensure the quality of APIs and ...

The Indian Pharmacopoeia Commission (IPC) has launched 10 new impurities standards for effective quality control analysis of pharmaceutical products in the country. With this, IPC will have a total of ...