Our Nitrosamine Studies are designed to detect and quantify nitrosamine impurities in pharmaceutical products, in compliance with FDA, EMA, and ICH guidelines. Nitrosamines are potentially carcinogenic compounds that can form during the manufacturing process, making their detection critical for product safety.

We offer comprehensive testing and risk assessments for:

• Identification and quantification of nitrosamine impurities in APIs and drug products
• Method development and validation for sensitive detection
• Compliance with regulatory limits set by health authorities
• Risk mitigation strategies for nitrosamine contamination

Using advanced techniques such as LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry), we ensure accurate, reliable, and timely results to support your regulatory submissions, product safety, and market approval.