The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated ...

The discovery of nitrosamine impurities in commonly prescribed drugs prompted regulatory authorities to implement a rapid response. The US Food and Drug Administration (FDA) and European Medicines ...

These medications could save thousands of lives – but doctors aren’t prescribing them - While it was once hoped that cytisine ...

We describe the identification of novel rapamycin derivatives present as low-level impurities in active pharmaceutical ingredients using an integrated, multidisciplinary approach. Rapamycin, a ...

Nitrosamine impurities are byproducts produced in trace amounts during the manufacturing processes of angiotensin receptor blocking (ARB) medications. However, these impurities are classified as ...

Discussion Genotoxic impurities can occur in drug products based on the manufacturing of the API, degradation of the API, or in some cases, from the excipients (9). The source of genotoxic impurities ...

Controlling and monitoring impurities in APIs and finished drug products is a crucial issue in drug development and manufacturing. Part I of this article, published in the February 2012 issue of ...

NDMA concentration levels in the APIs ranged from 0.156 ppm to 63.09 ppm. The risk of these doses of the impurities is relatively low.

Impurities other than MIs are generally measured in drug substances at concentrations exceeding 0.05% weight/weight or as the relative peak area, and the techniques used are standard according to ...