甲璜酸伊马替尼

TETS检验 STANDARD标准 RESULTS 结果 Appearance White or almost white powder white powder Solubility Easy to dissolve in the water Complies Identification High-performance liquid chromatograph HPLC Almost the same Infrared absorption Almost the same Melting point 222-227℃ 224-225º℃ Water ≤0.5% 0.3% Heavy metals ≤20ppm ＜20ppm Residue on ignition ≤0.1% 0.03% Related impurity Sigle impurity≤0.1% 0.04% Total impurity no more than 1.0% 0.3% HPLC assay 98.0%～102.0% 99.8% Package:Closed packing with moisture-proof plastic bag inside, packing with paper-plate boxes outside.（3kg-25Kg),moisture-proof plastic bag inside, packing with aluminum foil bag outside.(＜3kg) Conclusion: Complies With Enterprise Standard 2010符合企业标准2010版