The presence of nitrosamine impurities in pharmaceutical products to date has led the FDA (U.S. Food and Drug Administration) to publish its guidance on "Control of Nitrosamine Impurities in Human Pharmaceuticals" and require a risk assessment for all approved or marketed products within six months of its publication.
USP General Chapter "1469" Nitrosamine Impurities provides information on the development of test methods for the detection and measurement of Nitrosamine Impurities in drug ingredients and products. The USP Official Reference Standards and Pharmaceutical Analytical Impurities (PAI) are physical samples that can serve as benchmarks for impurity analysis.
You can purchase the USP Nitrosamine Impurities from this webshop. For quick location, simply enter the desired item number in the search box.
Do you have scientific questions about the use of Nitrosamine Impurity substances? Simply send a short e-mail to reference-standards@bpt.eurofinseu.com. We will be pleased to put you in touch with a USP expert for a well-founded answer to your questions.