The Indian Pharmacopeia Commission (IPC), operating under the Ministry of Health and Family Welfare (MoHFW), has introduced 7 Indian Pharmacopoeia Nitrosamine Impurities Reference Standards to enhance the precise detection and quantification of carcinogenic impurities in pharmaceutical products.
The 7 newly introduced reference standards comprise N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodibutylamine (NDBA), N-Nitrosomethylphenylamine (NMPA), N-Nitrosodiisopropylamine (NDIPA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The reference standards were officially launched during an interactive meeting titled “IP 2026: Perspectives, Suggestions, & Way Forward” organized by the IPC in Kolkata, West Bengal.
It is to be noted that nitrosamines are classified as highly potent genotoxic and carcinogenic compounds, which are substances capable of causing cancer or genetic mutations.