格列美脲
中文通用名 | ：格列美脲 |
用途类型 | ： |
规格 | ：EP/USP |
HS Code | ：29299090.90 |
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结构式 | ： |
CAS | ：93479-97-1 |
分子式 | ：C24H34N4O5S |
用途 | ：格列美脲是第三代磺酰脲类抗糖尿病药，具有抑制肝葡萄糖合成、促进肌肉组织对外周葡萄糖的摄取及促进胰岛素分泌的作用。本品适用于单纯饮食控制，运动疗法及减轻体重均不能充分控制血糖的2型糖尿病患者。 |
Items | Standard |
|---|---|
Appearance | White or almost white powder |
Solubility | Practically insoluble in water; Soluble in dimethylformanide; slightly soluble in methylene chloride, very slightly soluble in methanol. |
Identification IR | Conforms to glimepiride CRS |
Releated substances Impurity B Impurity C Impurity D Specified unidentified RRT 0.67 RRT 0.83 Unsoecified impurity,each sum of impurities other than B |
Not more than 0.4% Not more than 0.1% Not more than 0.2%
Not more than 0.1% Not more than 0.1% Not more than 0.5% |
Impurity A | Not more than 0.4% |
Assay (amhydrous substance) | Not less than 98.0% and not more than 102.0% |
Residual Solvents Acetone | Not more than 2000ppm |
Particle size distribution D100 D90 | Not more than 2000um Not more than 2000um |
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