Nitrosamine, Nitroso, and Azido Impurities Testing

Nitrosamine, nitroso, and azido impurities are carcinogens that may cause cancer in diverse organs and tissues including the lungs, brain, liver, kidney, bladder, stomach, esophagus, and nasal sinus.

The discovery of nitrosamines, nitroso, and azido Impurities in some types of drug substances and drug products led USFDA and other international regulators to conduct a detailed analysis of these impurities. The USFDA has advised the manufacturers to conduct risk assessments of their approved or marketed products and products with pending applications, and take appropriate actions to reduce or prevent the presence of nitrosamines, nitroso, and azido impurities in APIs and drug products.

Shiva Analyticals has over three decades of experience in analyses of impurities on the Mass Specs and has helped many Pharmaceutical manufacturers in producing contaminant-free products.

Shiva Analytocals has been working hand in hand with the Pharma Industry to produce nitrosamine, nitroso, azido free Sartans, and many other products through its unmatched analytical services worldwide. Equipped with the latest mass spec instruments like Waters UPLC H-Class MS/MS (TQS Micro), Waters LC-MS/MS (XEVO TQ-XS), and Agilent GC MS/MS (Triple Quad), we have successfully analyzed over 100 products for nitrosamines, nitroso, and azido impurities in drug substances, solvents, and drug products.

Please contact us for method development, method validation, and analysis of Nitrosamine, Nitroso, and Azido impurities in the Solvents, Dug substances, and Drug products