- Contact Person : Mr. Yu Tiejun
- Company Name : Shaanxi Dasheng Pharmaceutical Tech Co., Ltd.
- Tel : 86-29-88193551
- Fax : 86-29-88193353
- Address : Shaanxi,Xi'an,9F of Jiezuo Square, No.2 South Fenghui Rd., Hi-tech Industrial Developing Zone, Xi'an, China.
- Country/Region : China
- Zip : 710075
Prostate drug treatment of Bicalutamide
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| ITEM TESTED | STANDARD | RESULTS | |
Appearance | White or off-white crystalline Powder | White crystalline powder | |
Identification | A: Infrared absorption | Complies | |
B: The retention time of the major peak from the Sample solution corresponds to that of the Standard preparation, as obtained in the Assay. | Complies | ||
Tests | Water | Not more than 0.2% | 0.16% |
Residue on ignition | Not more than 0.1% | 0.08% | |
Heavy metals | Not more than 10ppm | Complies | |
Related substances | Des-fluoro analog not more than 0.2% 2-Fluoro isomer not more than 0.2% Des hydroxy analog not more than 0.2% Individual unspecified impurity not more than 0.1 % Total impurity is not more than 0.5% | 0.08% 0.09% 0.13% 00 0.3% | |
Assay | Bicalutamide contains not less than 98.0 percent and not more than 102.0 percent of C18H14F4N2O4S, calculated on the anhydrous and solvent-free basis. | 99.7% | |
Remarks: The material complies with respect to USP34. | |||
Prostate drug treatment of Bicalutamide