舒更葡糖钠；343306-79-6；肌肉松弛原料；药品注册申报标准；含量99%；仅供出口

舒更葡糖钠 含量99%以上，肌肉松弛原料，临床研究中，舒更葡糖钠成品 功能主治: 在成人中拮抗罗库溴铵或维库溴铵诱导的神经肌肉阻滞。

英文名称：Sugammadex sodium

CAS：343306-79-6

其它信息：纯度：99%HPLC

【舒更葡糖钠性状】Appearance性状Appearance 本品为白色或类白色粉末或颗粒，极具引湿性。

White or off-white powder or granules and is highly hygroscopic.

溶解度Solubility 本品在水中极易溶解，在乙腈、甲醇或无水乙醇中几乎不溶。

The product should be very soluble in water and practically insoluble in acetonitrile, methanol or absolute ethanol.

【鉴别Identification 供试品溶液色谱图中舒更葡糖钠峰和单-羟基舒更葡糖钠峰的保留时间及紫外吸收图谱应与对照品溶液中舒更葡糖钠和单-羟基舒更葡糖钠对应的保留时间与紫外吸收图谱一致。

The retention time and UV absorption spectrum of the Sugammadex Sodium and the mono-hydroxy Sugammadex Sodium in the chromatogram of the test solution should be correspond to the Sugammadex Sodium peak and the mono-hydroxy Sugammadex Sodium in the chromatogram in the reference solution. 

【检查】

 Analysis 酸碱度

pH 7.0～8.5

溶液的澄清度与颜色

Clarity and Color 

of solution 溶液应澄清；如显色，在350nm处测定吸收值，应小于0.75。

The solution should be clarified ;If color is developed, then the absorptivity is less than 0.75 at 350nm.

【检查】

 Analysis 有关物质1

Related substances 1

杂质P不得过0.3%

Impurity P : not more than 0.3%

杂质D不得过0.6%

Impurity D : not more than 0.6%

杂质B不得过0.3%

Impurity B : not more than 0.3%

杂质E不得过0.7%

Impurity E : not more than 0.7%

杂质C不得过0.3%

Impurity C : not more than 0.3%

杂质N不得过1.0%

ImpurityN : not more than 1.0%

杂质R不得过0.5%

ImpurityR : not more than 0.5%

杂质Q不得过0.3%

Impurity Q : not more than 0.3%

杂质S不得过0.5%

Impurity S : not more than 0.5%

杂质T不得过0.3%

Impurity T : not more than 0.3%

杂质O不得过0.5%

Impurity O : not more than 0.5%

杂质L不得过0.4%

Impurity L : not more than 0.4%

杂质H不得过0.3%

Impurity H : not more than 0.3%

杂质G不得过1.4%

Impurity G : not more than 1.4%

杂质F不得过0.3%

Impurity F : not more than 0.3%

杂质M不得过0.3%

Impurity M : not more than 0.3%

丙烯酸不得过0.1%

Acrylic acid : not more than 0.1%

三苯基氧膦不得过0.1%

Triphenylphosphine oxide : not more than 0.1%

其他未知单个杂质不得过0.1%

Unspecified impurities : not more than 0.1%

杂质总量不得过5.0%

Total impurities : not more than 5.0%

【检查】

 Analysis 有关物质2

Related substances 2 3-巯基丙酸不得过0.1%

3-Mercaptopropionic acid : not more than 0.1%

3,3-硫代二丙酸不得过0.1%

舒更葡糖钠 细菌内毒素符合客户要求