Indian Pharmacopoeia Commission Launches Seven Nitrosamine Standards

Key facts

• The Indian Pharmacopoeia Commission (IPC) launched seven nitrosamine impurity reference standards to strengthen detection and quality control of potentially harmful impurities in pharmaceutical products.
• The seven standards are 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).
• Nitrosamines are potent genotoxic and carcinogenic compounds that can unintentionally arise during pharmaceutical manufacturing, storage, packaging, or through contamination from materials used in drug production.
• The launch aims to support pharmaceutical testing, method validation, quality assurance, and regulatory compliance while promoting harmonisation with international quality standards and self-reliance in critical reference materials.