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A Validated HPLC/MS Limit Test Method for a Potential Genotoxic Impurity in Cilostazol and its Quantification in the API and in the Commercially Available Drug Product

Cilostazol is a selective inhibitor of type 3 phosphodiesterase. 5-(3-Chloropropyl)-1-cyclohexyl-1H-tetrazole, used as an intermediate in the synthesis of cilostazol, has a primary alkyl chloride group, a well-known alerting function for genotoxic activity. Upon request from a regulatory agency, a l...

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Detalles Bibliográficos
Autores principales:	Bray, Luigi, Monzani, Luca, Brunoldi, Enrico, Allegrini, Pietro
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	The Austrian Journal of Pharmaceutical Sciences 2015
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4727775/ https://www.ncbi.nlm.nih.gov/pubmed/26839820 http://dx.doi.org/10.3797/scipharm.1502-05

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