Docetaxel EP Impurity B

Development and validation of RP-​HPLC method for simultaneous estimation of docetaxel and ritonavir in PLGA nanoparticles
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By Kumbhar, P. S.; Diwate, Sonali K.; Mali, U. G.; Shinde, T. U.; Disouza, J. I.; Manjappa, A. S.
From Annales Pharmaceutiques Francaises (2020), 78(5), 398-407
 

 

Docetaxel EP Impurity B is chemically 5β,20-Epoxy-1,7β-dihydroxy-9,10-dioxotax-11-ene-2α,4,13α-triyl 4-acetate 2-benzoate 13-[(2R,3S)-3-[[(1,1-dimethylethoxy)carbonyl]amino]-2-hydroxy-3-phenylpropanoate] (as per EP); 2aR,4S,4aS,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11,12,12a,12b-Dodecahydro-4, 9,11,12,12b-pentahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]benz[1,2-b]oxet-5,6-dione 12b-acetate, 12-benzoate, 9-ester (as per USP). It is also known as 6-Oxo Docetaxel (USP) ; 10-Deoxy-10-Oxo Docetaxel (EP). Docetaxel EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Docetaxel EP Impurity B 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 Docetaxel.

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.