SPL Set ID: 2992d633-08fa-44f3-b14d-41700f24686b

1 drug(s) with this SPL Set ID

Open DailyMed details

Docetaxel DOCETAXEL ANHYDROUS
MYLAN INSTITUTIONAL LLC FDA Rx Only

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 is (2R,3S)-N-carboxy-3-phenylisoserine, N- tert -butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one4-acetate 2-benzoate. Docetaxel (anhydrous) has the following structural formula: Docetaxel, USP (anhydrous) is a white or almost white crystalline powder with an empirical formula of C 43 H 53 NO 14 , and a molecular weight of 807.88. It is highly lipophilic, soluble in methanol and practically insoluble in water. Docetaxel Injection, USP is a sterile, non-pyrogenic, clear, colorless to pale yellow solution at 10 mg/mL concentration. Each mL contains 10 mg docetaxel, USP (anhydrous), 260 mg polysorbate 80 NF, 4 mg anhydrous citric acid USP, 23% v/v alcohol USP (equivalent to 22.08% v/v absolute alcohol), and polyethylene glycol 300 NF. Docetaxel Injection, USP is available in multiple-dose vials containing 80 mg (8 mL) docetaxel, USP (anhydrous). Docetaxel Injection requires NO prior dilution with a diluent and is ready to add to the infusion solution. Chemical Structure

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