Regulatory requests that marketing authorization holders for chemically synthesized active
substances risk assess their medicines for the potential presence of N-nitrosamines have …

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 …

Downstream purification of products and intermediates is essential for the development of
continuous flow processes. Described herein, is a study on the use of a modular and …

The risk assessment and control of N-nitrosamine impurities in medicines is a topic of great
concern for patients, regulators, and the pharmaceutical industry. This paper discusses a …

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 …

To maximize the benefits of a continuous flow reaction, a continuous work-up is also
needed. Herein, we present a process design and novel equipment for a continuous amine …

We present a rapid continuous processing methodology to screen for the optimal, selective,
liquid–liquid extraction conditions, from a typical post-reaction mixture of amines, using both …

The increased usage of purge arguments for demonstrating control of mutagenic impurities
in drug substances, in accordance with ICH M7, necessitates an increasingly standardized …

A selective aziridinium ring-opening was used to etherify an α-aryl-β-amino alcohol with
stereochemical retention. This transformation was achieved in a biphasic system to address …

We report a strategy for implementing a scalable continuous extraction to drive an
equilibrium-limited reaction to completion. Our approach is simple, requiring only standard …