The detection of N-nitrosamine impurities in medicines and the recent emergence of
nitrosamine drug substance related impurities (NDSRIs) has posed a great challenge to …

The potential for active pharmaceutical intermediates and active ingredients to contain low
levels of N-nitrosamines is a topic of continued interest from industry and regulatory …

In 2019, N-nitrosodimethylamine (NDMA) exceeding the maximum allowable intake (96
ng/day) was detected in metformin drug products in Singapore, and since then, many of the …

Highlights•The development of digital tools is vital to quantify nitrosamines acceptable
intake, rate of generation, and purge.•Solution-phase kinetic models are used to determine …

Healthcare marketing authorization holders are undertaking widespread risk assessment
activities following the discovery of dialkyl N-nitrosamines in certain drug substances and …

This position study provides a science-based, holistic approach to evaluating the risks of
nitrosamine presence in drug-linkers as intermediates toward antibody–drug conjugate …

Drug recalls have led to increased regulatory scrutiny into the formation and presence of
nitrosamine (N-nitrosoamine) impurities in medicines. This review aims to assist the …

A new route to the cannabinoid receptor type 2 agonist, RG7774, has been developed
circumventing an alkylation with poor regioselectivity as the final step. In the new synthetic …

Polysorbates and Pluronic polymers are straightforward to use to improve the performance
of hydrophobic molecules, however, colloidal systems of these polymers are not fully …

Synthetic routes to drug substances can result in the introduction of potentially mutagenic
impurities (PMIs). The ICH M7 guideline offers a range of control options that assures that …