Nitrosamines

Around the world mandatory testing of active pharmaceutical ingredients (APIs) is required to demonstrate that pharmaceutical products are safe for use.

 

Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of secondary amines with nitrite under acidic conditions, they have been studied for many years due to their presence in foods, cosmetics, tobacco products, industrial solvents, and alcoholic beverages.

In 2018, nitrosamine impurities were found in a number of blood pressure medicines known as “sartans” and immediate action was taken to recall potentially contaminated medicines and set strict guidelines for the manufacture. Since then, nitrosamine impurities have subsequently been found in other medicines, and the European Medicines Agency (EMA) have conducted a review into their presence in medicines.

Class 1 impurities

Nitrosamines are classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens”. Although EMA concluded that there was very low risk of carcinogenic activity at the levels detected, manufacturers are obliged to take steps to limit the presence of nitrosamines in their products and to test all products where the risks cannot be sufficiently mitigated.

In addition, the EMA and national authorities actively monitor the presence of these impurities in medicines, and to work with manufacturers to address any adverse findings.

How can we help

RPS have significant experience of testing for nitrosamines in environmental and food and drink samples, typically at very low levels. Our analytical expertise, combined with our experience in Good Laboratory Practice (GLP), gives us the ability not only to analyse API samples, but also to generate a report that meets regulatory needs and will guide you to compliance.

Using state of the art equipment, the Orbitrap LC-MS will provide high-resolution accurate-mass analysis, enabling us to conduct robust testing for a range of nitrosamine impurities. Analysis of ultra low-level impurities is complex, but our team have the expertise to support your needs.

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