N-Nitroso Betahistine EP Impurity C

Stress degradation studies on betahistine and development of a validated stability-indicating assay method
Alaa Khedr a, Mahmoud Sheha
Journal of Chromatography B, 869 (2008) 111–117
 
Characterization and in silico Mutagenic Assessment of a New Betahistine Degradation Impurity
Murilo B. M. de Mello,a,# Antonio A. F. de Oliveira,b,# Caroline L. de Oliveira,b Mariah A. Ultramari,b Fernando H. S. Gama,b Alessandra Mascarello,b Cristiano R. W. Guimarães,b Miller N. de Freitas,b Carlos E. Cunha,c Tiago C. Lourenço,d Fernanda P. Ferreira,e João L. C. Lopesa,f and Giuliano C. Clososki
J. Braz. Chem. Soc., Vol. 30, No. 7, 1415-1424, 2019

N-Nitroso Betahistine EP Impurity C is chemically N,N-Bis(2-(pyridin-2-yl)ethyl)nitrous amide. N-Nitroso Betahistine EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Betahistine EP Impurity C 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 Betahistine.

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.