Benzenepropanoic acid, β-[[(1,1-dimethylethoxy)carbonyl]amino]-α-hydroxy-, (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-12b-(acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-11-hydroxy-4,6-dimethoxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester, (αR,βS)-;
1-Hydroxy-7β,10β-dimethoxy-9-oxo-5β,20-epoxytax-11-ene-2α,4,13α-triyl 4-acetate 2-benzoate 13-[(2R,3S)-{[(1,1-dimethylethoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoate];
4-(Acetyloxy)-13α-{[(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-7β,10β-dimethoxy-9-oxo-5β,20-epoxytax-11-en-2α-yl benzoate
[183133-96-2] Cabazitaxel acetone solvate C45H57NO14·C3H6O 894.02
[1426815-65-7]
BRIEFING
Cabazitaxel. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure used in the Assay and Organic Impurities test was validated using the Ascentis Express C18 brand of column with L1 packing. The typical retention time for cabazitaxel is about 14 min.
This proposal has been partially retroactively aligned with cabazitaxel acetone from European Pharmacopoeia 11.4.
Description and solubility: White to almost white powder. Soluble in dehydrated alcohol; practically insoluble in water and in heptane.
(SM3: M. Jonnada)
Case ID—SUB-1685, SUB-1687
USP REFERENCE STANDARDS FOR PURCHASE
USP Acetone RSUSP Cabazitaxel Acetone RS
USP Cabazitaxel System Suitability Mixture RS