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Nitrosamine Impurities in Pharmaceuticals: Ensuring Safety and Compliance

Nitrosamine compounds are potent genotoxic agents [1], have become a critical concern in pharmaceutical products. Their detection as impurities was first reported in 2018, with N-nitrosodimethylamine (NDMA) found in valsartan, an angiotensin II receptor blocker (ARB). Since then, regulatory agencies such as the US FDA, EMA, and Health Canada have mandated strict control measures to ensure patient safety.

Formation of nitrosamines is possible in the presence of secondary amines, tertiary and quaternary amines and nitrile salts under acidic reaction conditions. APIs that contain secondary amine or dimethyl tertiary amine centers are at risk of forming Nitrosamine Drug Substance-Related Impurities (NDSRIs) by nitrosation of the amine center. This can occur under conditions related to the synthesis of API, the formulation and manufacturing process for the drug product, such as by reaction with residual nitrites in excipients used to formulate the drug product.

Here are key points regarding nitrosamine impurities:

Types of Nitrosamines:

• Nitrosamines include compounds like NDMA, NDEA, NDIPA, NEIPA, and NMBA. They can enter products during processing or form as impurities during API production or formulation.

• Nitrosamine Drug Substance-Related Impurities (NDSRIs) by nitrosation of the amine center location.

Challenges in Testing

• Nitrosamines often occur at low levels, making their detection challenging.

• Traditional methods like LC-UV are inadequate.

• Specialized equipment like LC-MS/MS is required for accurate quantification.

Our Nitrosamine Impurities Testing Services

• Identification and Quantification: We can detect and quantify nitrosamine traces in drug products, raw materials, APIs, and packaging.

• Method Development: Our expertise in LC-MS/MS ensures robust methods.

• Optimized Extraction Procedures: We reach relevant LOD and LOQ levels in drug products.

LC-MS/MS Platform Method:

• Our targeted and screening approach uses LC-MS/MS.

• We offer method development.

• Characterization of nitrosamine impurities is part of our expertise.

• Ensuring the absence of nitrosamine impurities is crucial for patient well-being. Let us assist you in maintaining safety and compliance in your pharmaceutical products.

• Our Lab houses Two LC-MS/MS systems from triple quadrupole to Qtrap and has performed many

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