Cimetidine Nitroso Impurity 1

Sulfur-Specific Detection of Impurities in Cimetidine Drug Substance Using Liquid Chromatography Coupled to High Resolution Inductively Coupled Plasma Mass Spectrometry and Electrospray Mass Spectrometry
E. Hywel Evans,*,† Jean-Claude Wolff,‡ and Christine Eckers
Anal. Chem. 2001, 73, 4722-4728
 
Determination of cimetidine and related impurities in pharmaceutical formulations by high-performance liquid chromatography
P. Betto, E. Ciranni-Signoretti* and R. Di Fava
Journal of Chromatography, 586 (1991) 149-152
 
Simultaneous Determination of Cimetidine and Related Compounds in Pharmaceuticals by HPLC on a Porous Graphitic Carbon Column
N. Helali, L. Monser
Chromatographia volume 63, pages425–430(2006)

Cimetidine Nitroso Impurity 1 is chemically (E)-2-Cyano-1-methyl-3-(2-(((5-methyl-1-nitroso-1H-imidazol-4-yl)methyl)thio)ethyl)-1,3-dinitrosoguanidine. Cimetidine Nitroso Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Cimetidine Nitroso Impurity 1 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Cimetidine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.