Function: | Antiparasitic |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Standard: | USP |
Samples: |
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Tests | Specifications | Results | |
Appeaeance | White to off-white crystalline powder | Conforms | |
Identification | IR | A.The IR spectrum of the sample correspends to that of the refenence standard | Conforms |
HPLC | B.The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of Standard preparation,as obtained in the Assay | Conforms | |
Water | ≤0.2% | 0.19% | |
Residue on ignition | ≤0.1% | 0.06% | |
Heavy metals | ≤10ppm | Conforms | |
Related Substances | Bicalutamide Aminobenzonitrile(RRT0.30)≤0.1% | N.D | |
Bicalutamide Related Compound A Isomer A(RRT0.64)≤0.1% | N.D | ||
Bicalutamide Related Compound A Isomer B(RRT0.67)≤0.1% | N.D | ||
Desfluoro Bicalutamide(RRT0.83)≤0.2% | 0.0074% | ||
2-Fluoro Bicalutamide(RRT0.94)≤0.2% | 0.0011% | ||
Deoxybicalutamide(RRT1.33)≤0.2% | N.D | ||
Bicalutamide Sulfide(RRT1.56)≤0.1% | N.D | ||
Any Unspecified Impurity≤0.1% | 0.031% | ||
Total Impurities≤0.5% | 0.10% | ||
Residual Solvents | Tetrahydrofuran≤0.072% | N.D | |
Toluene≤0.089% | N.D | ||
N-hexane≤0.029% | 0.00016% | ||
Acetone≤0.5% | 0.26% | ||
Ethyl Acetate≤0.5% | N.D | ||
N,N-Dimethyl Acetamide≤0.109% | N.D | ||
Microbiological purity | TAMC | Conforms | |
TYMC | Conforms | ||
Absence of Escherichia coli in 1g | Conforms | ||
Assay | 98.0%-102.0% | 99.4% |
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