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2018年6月7日国家药品监督管理局承办 1 个关联审评审批的原料药连云港润纵制药有限公司甲磺酸伊马替尼)。

原辅包 | 6.7日CDE承办1个API

Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder.  Its molecular formula is C29H31N7O · CH4SO3 and its relative molecular mass is 589.7.  Imatinib mesylate is very soluble in water and soluble in aqueous buffers ≤ pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol and ethanol, but is insoluble in  n-octanol, acetone and  acetonitrile.


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