The chemical synthesis and supply of a drug substance is a time critical step in the process of defining and selecting a lead drug candidate for progress into a toxicology program and subsequently into first-in-human clinical trials. The presence of impurities can hinder toxicology results and delay entry into the clinic therefore it is important to identify and mitigate this risk. There are multiple potential causes of the formation or introduction of impurities regardless of the synthesis route used, including the materials used, the process conditions, potential cross-contamination, etc., and these can lead to several types of impurities.
The recent recalls of sartans and other medicinal products due to the presence of N‑nitrosamine impurities, increased the awareness of the impact of material selection, process changes, and cross-contamination, as well as the limitations of the existing analytical methods used. Many N‑nitrosamines are known to be carcinogenic to animals and are reasonably anticipated to be human carcinogens.
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