N-Nitroso Hydroxyzine EP Impurity A

Method for the control of known impurities in hydroxyzine hydrochloride
D. Simpson a'*, G.G. Skellern a, J.H.McB. Miller b
Journal of Pharmaceutical and Biomedical Analysis 14 (1996) 1371-1375
 
A High Performance Liquid Chromatography Method for Determination of Hydroxyzine Hydrochloride in Syrup
A.f. brandão 1,2 *, luiz g.b. nascimento 1, hudson c. polonini 1, roberta g. fonseca 2, gabriela montesano 1, urias p. vaz 1, nádia r.b. raposo 1, lívia n. grossi 2 & anderson o. ferreira
Lat. Am. J. Pharm. 30 (9): 1798-1802 (2011)

N-Nitroso Hydroxyzine EP Impurity A is chemically 1-((4-Chlorophenyl)(phenyl)methyl)-4-nitrosopiperazine. N-Nitroso Hydroxyzine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Hydroxyzine EP Impurity A 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 Hydroxyzine.

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.