Assessing Nitrosamine Impurities In Your Pharmaceutical Product

Assessing Nitrosamine Impurities In Your Pharmaceutical Product


Nitrosamine impurities are potential mutagenic carcinogens that present a major safety concern even at trace amounts. Several drug products have been recalled from the market due to unacceptable levels of nitrosamine contaminants. International regulators require pharmaceutical companies to proactively determine whether their medicines are at risk of containing nitrosamines. To ensure patient safety, appropriate steps should be taken to prevent these impurities from being present in their drug products.

The FDA and EMEA have provided guidance to industry on nitrosamine assessments. The approach involves a risk evaluation of the API and finished product processes, excipients, and packaging system for nitrosamines. If a risk is identified, the presence or absence of the nitrosamine must be determined, and outcomes reported. If a nitrosamine is confirmed to be present, corrective actions must be taken to prevent or reduce the risks through submission of a variation.

PharmSky’s Solution

PharmSky provides expertise in nitrosamine risk assessments and control strategies to minimize the risk of potential nitrosamines. Equipped with highly sensitive instruments, GC-MS/MS (Triple Quadrupole) and LC-QToF MS, and knowledge of pharmacopoeia guidelines (USP <1469> and EP 2.5.42), PharmSky can develop targeted methods to test for nitrosamine contaminants and nitrosamine drug substance related impurities at trace amounts. Contact us for more information about our nitrosamine services.


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