Specification :

1. Chemical Name:
N-[ 4-Cyano-3- trifluoromethyl phenyl] -3-[  4-fluorophenyl sulfonyl] -2-h ydroxyl-2- methylpropanemide
2. CAS RN: 90357-06-5
3. Structural Formula:
4. Molecular formula & molecular weight: C18H14F4N2O4S 430.38
5. Appearance: It’ s a white or almost white crystal powder, odorless, tasteless, freely soluble in DMF; Soluble in butylene oxide; sparingly soluble in acetic ether and methanol; insoluble in water.
6. Quality Standard: Enterprise standard C18H14F4N2O4S e99
Identification 1. IR Infrared absorption spectrohotometry confirm
2. UV Maximum absorption at 271± 2 nm
3. MP Between 191 and 195
4. Positive reaction Positive reaction
Tests Fluorin Between 15.9% and 17.6%
Related substances Total impurity is not more than 1.0%
Loss on drying Not more than 0.5% ( 105 )
Residue on ignition Not more than 0.2%
Heavy metals Not more than 20ppm
Assay
( By HPLC) Bicalutamide contains not less than 98.0% and not more than the equivalent of 102.0 of C18H14F4N2O4S, calculated with reference to the dried substance.
7. Usage: Prostate drug, It is developed by AstraZenca Internatioal, and it is the first antiandrogen non-corticosteroids drug for long-acting oral medication and firstly go on the market in 1995 in UK. An antiandrogen non-corticosteroids can be used treating prostate cancer in advanced stage as assistant drug, may also for treating prostate cancer in the early stage to play an important role.
8. Storage: It should be kept in room temperature, and away from light; stored in sealed containers.
9. Packing: Paper bucket, 10kg/ package.
10. HS CODE: 2937 0000.90