溶解度

Solubility

本品在二甲基亞砜中易溶，在二氯甲烷中微溶，在水中幾乎不溶。

Freely soluble in dimethyl sulfoxide,slightly soluble in dichloromethane,practically insoluble in water.

在二甲基亞砜中易溶，在二氯甲烷中微溶，在水中幾乎不溶。

Freely soluble in dimethyl sulfoxide,slightly soluble in dichloromethane,

practically insoluble in water.

符合規(guī)定

Complies

【鑒別】

Identification

紅外鑒別

Infrared Absorption

供試品的紅外光吸收圖譜應與對照品的紅外圖譜一致。

The infrared absorption spectrum of the  sample shall be consistent with that of the reference substance.

符合規(guī)定

Complies

符合規(guī)定

Complies

液相色譜

HPLC

供試品主峰的保留時間應與對映體與非對映體純度測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.

符合規(guī)定

Complies

符合規(guī)定

Complies

【檢查】

 Analysis

有關物質(zhì)

Organic impurities

任意單個雜質(zhì)應不得過0.1%

Individual impurities not more than 0.1%

0.0081%

符合規(guī)定

Complies

總雜質(zhì)應不得過0.3%

Total impurities not more than 0.3% 

0.019%

【檢查】

 Analysis

對映體

Enantiomeric

6R，12aS非對映異構體不得過0.1%

6R,12aS diastereomer not more than 0.1%

未檢出

Not detected

符合規(guī)定

Complies

6S，12aS對映異構體不得過0.1%

6S,12aS enantiomer not more than 0.1%

未檢出

Not detected

6S，12aR非對映異構體不得過0.1%

6S,12aR diastereomer not more than 0.1%

未檢出

Not detected

殘留溶劑

Residual solven

甲胺不得過0.163%

Methylamine not more than0.163% 

未檢出

Not detected

符合規(guī)定

Complies