The U.S. Food and Drug Administration (FDA) has prepared a guide for the industry titled “Control of nitrosamine impurities in human drugs”. This guide covers steps that manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent objectionable levels of nitrosamine impurities in pharmaceutical products. This guide also describes the conditions that cause nitrosamine impurities. The unexpected detection of nitrosamine impurities, which are possible human carcinogens, in some drugs clearly highlighted the need for a risk assessment strategy to identify and minimize nitrosamines in any pharmaceutical product.
Nitrosamines are pollutants commonly found in low amounts (ppm) in foods, beverages, cosmetics, water, tobacco products and consumer goods. In recent years, industry and regulators have identified much about what factors contribute to the risk of nitrosamine impurities in pharmaceuticals. These factors can be process related, supply chain related or stability related. Physicochemical properties of starting materials, intermediates or drug substance, specific process conditions, impurities or reactions in raw materials, or development and control strategies cause nitrosamine impurities. The use of recovered or recycled materials or other intermediates contaminated with nitrosamines and cross-contamination in multi-purpose plants also cause nitrosamine impurities. Likewise, drug substance or drug stability and excipient compatibility also cause nitrosamine impurities.
The FDA 2020-D-1530 standard, developed by the Food and Drug Administration (FDA) , describes the requirements for nitrosamine impurities and defines the analytical methods.
Nitrosamine impurities may increase the risk of cancer in humans if there is prolonged exposure. Studies show that there is no risk of cancer in people who take a nitrosamine-containing drug every day for 70 years at or below acceptable daily intake limits. However, the presence of nitrosamine impurities in some types of drugs continues to be investigated by the FDA.
Our organization also provides nitrosamine analysis services within the scope of FDA 2020-D-1530 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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