SPL Set ID: bc7b4eac-3b63-53d2-e053-2995a90ad5e7

Fulvestrant injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol. The molecular formula is C 32 H 47 F 5 O 3 S and its structural formula is: Fulvestrant, USP is a white powder with a molecular weight of 606.77. The solution for injection is a clear, colorless to yellow, viscous liquid. Fulvestrant injection is supplied as two 5 mL clear glass barrels, each containing 250 mg/5 mL of fulvestrant injection solution for intramuscular injection. Each injection contains as inactive ingredients: 12.29% v/v Alcohol, USP; 10% w/v Benzyl Alcohol, NF; 15% w/v Benzyl Benzoate, USP as co-solvents; and made up to 100% w/v with Castor Oil, USP as a co-solvent and release rate modifier. 16