【性状】
Appearance
性状
本品应为白色或类白色粉末。
white or almost white powder.
白色粉末
White powder
符合规定
Complies
溶解度
Solubility
本品在二甲基亚砜中易溶,在二氯甲烷中微溶,在水中几乎不溶。
Freely soluble in dimethyl sulfoxide,slightly soluble in dichloromethane,practically insoluble in water.
在二甲基亚砜中易溶,在二氯甲烷中微溶,在水中几乎不溶。
Freely soluble in dimethyl sulfoxide,slightly soluble in dichloromethane,
practically insoluble in water.
【鉴别】
Identification
红外鉴别
Infrared Absorption
供试品的红外光吸收图谱应与对照品的红外图谱一致。
The infrared absorption spectrum of the sample shall be consistent with that of the reference substance.
液相色谱
HPLC
供试品主峰的保留时间应与对映体与非对映体纯度测定中的定位溶液一致。
The retention time of the major peak of the Sample solution corresponds to that of the Identification solution, as obtained in the test for Enantiomeric and Diastere-omeric Purity.
【检查】
Analysis
有关物质
Organic impurities
任意单个杂质应不得过0.1%
Individual impurities not more than 0.1%
0.0081%
总杂质应不得过0.3%
Total impurities not more than 0.3%
0.019%
对映体
Enantiomeric
6R,12aS非对映异构体不得过0.1%
6R,12aS diastereomer not more than 0.1%
未检出
Not detected
6S,12aS对映异构体不得过0.1%
6S,12aS enantiomer not more than 0.1%
6S,12aR非对映异构体不得过0.1%
6S,12aR diastereomer not more than 0.1%
残留溶剂
Residual solven
甲胺不得过0.163%
Methylamine not more than0.163%
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