Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing From Experienced Industry Leaders

A key focus of this white paper is the analysis and testing of nitrosamines—potential carcinogens present in food, beverages, cosmetics, and pharmaceuticals. The FDA's recommended daily intake limits for nitrosamines necessitate stringent control measures for these substances in Active Pharmaceutical Ingredients (APIs) and drug products. Nitrosamines can originate from various sources, including contaminants in starting materials, solvents, catalysts, and even packaging components. Cambrex supports manufacturers in managing these risks through Chemistry, Manufacturing, and Controls (CMC) solutions, risk assessments, and mitigation strategies like optimizing reaction conditions and adding antioxidants.

Cambrex Analytical Services excels in nitrosamine analysis using advanced mass spectrometry techniques, including UPLC triple quadrupole MS/MS, UPLC Q-ToF, and headspace GC-MS/MS. These methods, validated for high sensitivity and specificity, are crucial for detecting nitrosamines at parts per billion (ppb) levels. Cambrex also offers custom synthesis of nitrosamines and performs studies to assess potential nitrosamine formation. Effective sample preparation and analysis are essential to avoid false negatives and ensure accurate results. Cambrex's state-of-the-art technology and experienced professionals enable pharmaceutical companies to meet regulatory requirements and achieve commercial milestones, making Cambrex a trusted partner for pharmaceutical product development.