Health Canada requires testing for certain human pharmaceutical products for detection, identification and quantification of nitrosamine impurities by Market Authorization Holders (MAHs). This requirement is part of Health Canada’s efforts to mitigate the risk of nitrosamine contamination for all active pharmaceutical ingredients (APls) in finished drug products (including Generic and over-the-counter (OTC) products), raw materials, and chemically synthesized APIs.
Laboratory testing for the presence and identification of nitrosamine beyond established limits in any pharmaceutical product is the critical first step of a risk assessment strategy. This supports drug manufacturers identify contributing factors and level of risk of nitrosamines by performing gap assessments and if required, changes to the manufacturing and control processes.
To determine presence of nitrosamines, we have developed, validated, and qualified analytical methods using LC MS/MS to perform trace-level risk assessments for the following:
- N-nitrosodimethylamine (NDMA)
- N-nitroso-diethyl amine (NDEA)
- N-ethyl-N-nitroso-2-propanamine (NEIPA)
- N-nitroso-diisopropylamine (NDIPA)
- N-nitroso-di-n-propylamine (NDPA)
- N-nitroso-methyl phenylamine (NMPA)
- N-nitroso-di-n-butylamine (NDBA)
- N-nitroso-N-methyl-4-aminobutyric acid (NMBA)
Contact our experts in LCS/MS/MS to discuss your specific requirements further.