Nitrosamine

High-Purity Nitrosamine Reference Standards for FDA and EMA Regulatory Compliance

Clinivex supplies a comprehensive portfolio of certified nitrosamine impurity standards formulated to support the complete analytical workflow from root cause investigation and confirmatory testing to validated quantification methods and ongoing quality monitoring. Our catalog features individually certified compounds including the NDMA reference standard (N-Nitrosodimethylamine), NDEA (N-Nitrosodiethylamine), NMBA (N-Nitrosomethylbenzylamine), and an expanding range of drug substance-specific nitrosamines identified under the FDA’s nitrosamine risk evaluation framework. Each standard is prepared at precisely assigned concentrations in appropriate solvent matrices, verified through validated LC-MS/MS, GC-MS, and GC-TEA analytical methods, and confirmed for structural identity via NMR and high-resolution mass spectrometry. For comprehensive genotoxic impurity coverage beyond nitrosamines, our drug impurity reference standards portfolio provides the full spectrum of ICH Q3A/Q3B compliant reference materials for pharmaceutical safety assessment.

As a trusted nitrosamine reference standards supplier serving regulated pharmaceutical laboratories across the USA and global markets, Clinivex ensures every product is accompanied by a comprehensive Certificate of Analysis (CoA) detailing purity assignment, uncertainty of measurement, solvent composition, and recommended storage conditions consistent with ICH M7(R1), FDA guidance on nitrosamine impurities, and EMA Article 31 referral requirements. Our materials are produced and qualified under GMP-compliant and ISO 17025-accredited conditions, giving your quality and regulatory teams the documentation confidence needed for ANDA, NDA, and MAA filings. Reach out to our technical team for expert guidance on selecting the appropriate nitrosamine standards for your specific drug substance or finished product testing program.