Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product -Nitrosamine Impurities.

The potential for -nitrosamine impurities in pharmaceutical products presents a challenge for the quality management of medicinal products. -Nitrosamines are considered cohort-of-concern compounds due to the potent carcinogenicity of many of the structurally simple chemicals within this structural class. In the past 2 years, a number of drug products containing certain active pharmaceutical ingredients have been withdrawn or recalled from the market due to the presence of carcinogenic low-molecular-weight ,-dialkylnitrosamine impurities.