SPL Set ID: 8e7747d8-0e4f-4284-9cd1-407d0fe5b946
1 drug(s) with this SPL Set ID
Bicalutamide Tablets, USP contain 50 mg of bicalutamide, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl) sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and molecular formulas are: Bicalutamide, USP has a molecular weight of 430.37. The pKa' is approximately 12. Bicalutamide is a white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. Each bicalutamide tablet, USP intended for oral administration contains 50 mg of bicalutamide. In addition each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. The product meets USP Dissolution Test 2. Image