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Details:
Bicalutimide
CAS RN: 90357-06-5
Chemical name: N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxyl-2- methylpropanemide
Synonyms: Bicalutamide (Subject to patent free); 4-cyano-3-trifluoromethyl-N-(3-p-fluorophenylsulfonyl-2-hydroxy-2-methylpropionyl)aniline; N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methyl-propanamid; [(4- fluorophenyl) sulfonyl]-2-hydroxy- 2-methyl propanamide ; N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide; (2S)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide
Molecular formula:C18H14F4N2O4S
molecular weight: 430.38
Characters: 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.
Quality Standard: EP9.0/USP39
Specification:
Item |
Standard |
Appearance |
White to off-white powder |
Solubility |
Freely soluble in tetrahydrofuran and acetone; soluble in acetonitrile; sparingly soluble in methanol; slightly soluble in alcohol. |
Identification |
A: infrared spectrum |
Infrared absorption spectrohotometry confirm |
B: hplc |
The sample spectrum corresponds to standard |
Specific optical rotation |
+25.0° ~+27.5° |
Residue on Ignition |
NMT 0.1% |
Heavy metals |
NMT 10ppm |
Water |
NMT 0.2% |
Organic impurities |
NMT 0.1% |
Bicalutamide aminobenzonitrile |
NMT 0.1% |
Bicalutamide relate compound A isomer A |
NMT 0.1% |
Bicalutamide relate compound A isomer B |
NMT 0.1% |
Desfluoro bicalutamide |
NMT 0.2% |
2-Fluoro bicalutamide |
NMT 0.2% |
Deoxybicalutamide |
NMT 0.2% |
Bicalutamide sulfide |
NMT 0.1% |
Any unspecified impurity |
NMT 0.1% |
Total impurities |
NMT 0.5% |
Residual Solvent |
DMAC≤1090ppm |
Ethanol≤1000ppm |
Dichloromethane≤300ppm |
Ethyl acetate≤1000ppm |
MIBK≤1000ppm |
Petroleum ether≤1000ppm |
Benzene≤2ppm |
Assay |
98.0%-102.0% |
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.
Storage:
It should be kept in room temperature, and away from light; stored in sealed containers.
Packing: paper bucket, 25kg/package.