Nitrosamine Testing Laboratory India | ICH M7 | NABL

Nitrosamine impurities have emerged as one of the most critical quality and safety challenges in pharmaceutical manufacturing. These probable human carcinogens — including NDMA, NDEA, NMBA, NIPEA, and NDIPA — can form through multiple pathways during drug synthesis, storage, and packaging interactions. Auriga Research provides NABL-accredited nitrosamine testing services using validated LC-MS/MS methods capable of detecting these compounds at parts-per-billion levels, well below established acceptable intake limits.

Our nitrosamine testing programme supports the regulatory requirements established by FDA, EMA, Health Canada, and CDSCO. We perform confirmatory testing for all six commonly monitored nitrosamines, as well as method development for drug-substance-specific nitrosamine impurities (NDSRIs) that may form from the active ingredient itself. Each analysis includes matrix-matched calibration, isotope-labelled internal standards, and reporting against product-specific acceptable intake limits calculated from maximum daily dose.

We also support risk assessment programmes by providing analytical data for root cause investigation, process optimisation verification, and ongoing monitoring of marketed products to ensure continued compliance with evolving regulatory expectations.