SPL Set ID: 67508df6-b96f-46fa-a792-0afcdfa9810e

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel anhydrous is benzenepropanoic acid, β-[[(1,1-dimethylethoxy) carbonyl) amino]-α-hydroxy-, 12b- (acetyloxy)-12-(benzoyloxy)-2a,3,4,4a,5,6,9,10,11,12,12a,12b-dodecahydro-4,6,11-trihydroxy-4a,8,13,13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-yl ester. Docetaxel anhydrous has the following structural formula: Docetaxel anhydrous, USP is a white or almost white crystalline powder with an molecular formula of C 43 H 53 NO 14 , and a molecular weight of 807.88. It is practically insoluble in water, soluble in acetone and methanol. One-vial Docetaxel Injection, USP Docetaxel Injection, USP is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration. Each mL contains 20 mg docetaxel anhydrous USP, 0.4 mg citric acid anhydrous in 0.54 g polysorbate 80 and 0.395 g dehydrated alcohol (50% v/v) solution. Docetaxel Injection, USP is available in single-dose vials containing 20 mg (1 mL), 80 mg (4 mL) and 160 mg (8 mL) docetaxel anhydrous, USP. Docetaxel Injection, USP requires NO prior dilution with a diluent and is ready to add to the infusion solution. 1