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?qǐng)D譜應(yīng)與對(duì)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(shí)間應(yīng)與對(duì)映體與非對(duì)映體純度測(cè)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(guān)物質(zhì)

Organic impurities

任意單個(gè)雜質(zhì)應(yīng)不得過(guò)0.1%

Individual impurities not more than 0.1%

0.0081%

符合規(guī)定

Complies

總雜質(zhì)應(yīng)不得過(guò)0.3%

Total impurities not more than 0.3% 

0.019%

【檢查】

 Analysis

對(duì)映體

Enantiomeric

6R，12aS非對(duì)映異構(gòu)體不得過(guò)0.1%

6R,12aS diastereomer not more than 0.1%

未檢出

Not detected

符合規(guī)定

Complies

6S，12aS對(duì)映異構(gòu)體不得過(guò)0.1%

6S,12aS enantiomer not more than 0.1%

未檢出

Not detected

6S，12aR非對(duì)映異構(gòu)體不得過(guò)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(guò)0.163%

Methylamine not more than0.163% 

未檢出

Not detected

符合規(guī)定

Complies