甲磺酸伊马替尼
中文通用名 | ：甲磺酸伊马替尼 |
用途类型 | ：抗生素类 |
规格 | ：EP/USP |
HS Code | ：29335990.90 |
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结构式 | ： |
CAS | ：220127-57-1 |
分子式 | ：C29H31N7O·CH4O3S |
用途 | ：用于治疗慢性粒细胞白血病(CML)急变期、加速期或α-干扰素治疗失败后的慢性期患者；不能手术切除或发生转移的恶性胃肠道间质肿瘤（GIST）患者。 |
Items | Standard |
|---|---|
Appearance | White to off-white crystalline or pale yellow powder |
Solubility | Soluble in water and sparingly soluble in methanol |
Identification | IR: Conforms to reference spectrum HPLC: the principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution Chemical identification: Positive reaction |
Melting point | 224°-229° |
Related substances(HPLC) Any single impurities Total impurities | ≤0.10% ≤0.50% |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.1% |
Heavy metals | ≤20ppm |
Residual solvents ethanol | ≤5000ppm |
2-propanol | ≤5000ppm |
Dichloromethane | ≤600ppm |
Methanol | ≤3000ppm |
Ethylacetate | ≤5000ppm |
Pyridine | ≤200ppm |
Assay of methanesulfonic acid | 15.0%-17.0% |
Assay On dry substance(HPLC) | 98.0%~102.0% |
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