Determination of Nitrosamines in Metformin Drug Substances with Orbitrap GC-MS

The ICH M7 (R1) guidelines categorizes nitrosamines as Class 1 impurities (mutagenic carcinogens) and the International Agency of Cancer Research (IARC) classifies them as probable carcinogens. A validated workflow for the determination of nitrosamines in pharmaceutical substances is therefore critical for quick and early mitigation.

The high-resolution accurate-mass capabilities of the Thermo Scientific™ Orbitrap Exploris™ GC mass spectrometer operated in selected ion monitoring mode with multiplexing can achieve the quantitation limits required by the regulatory methods. Furthermore, the 21 CFR part 11 compliant Thermo Scientific™ Chromeleon™ CDS software allows one to easily set up acquisition methods and provides a powerful workflow for targeted quantitation.

Presenter: Dr. Suresh Seethapathy (Senior Applications Scientist, Thermo Fisher Scientific)

Suresh is a Senior Applications Scientist and a member of the GC and GC‑MS applications support team at Thermo Fisher Scientific. Suresh obtained his Ph.D. at the University of Waterloo in Canada and has special interest in the areas of sample preparation, GCxGC, and small molecule compound identification. He currently supports GC and GC-MS hardware, software, and applications demonstration, specializing in the GC Orbitrap series.