Docetaxel 13-Oxo impurity

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 13-Oxo impurity is chemically (2aR,4S,4aS,6R,12S,12bS)-12b-acetoxy-11-hydroxy-4a,8,13,13-tetramethyl-5,9-dioxo-4,6-bis(((2,2,2-trichloroethoxy)carbonyl)oxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-1H-7,11-methanocyclodeca[3,4]benzo[1,2-b]oxet-12-yl benzoate. Docetaxel 13-Oxo impurity is supplied with detailed characterization data compliant with regulatory guideline. Docetaxel 13-Oxo impurity 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.