他达那非

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.

符合规定

Complies

【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.

符合规定

Complies

符合规定

Complies

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.

符合规定

Complies

符合规定

Complies

【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%

符合规定

Complies

总杂质应不得过0.3%

Total impurities not more than 0.3% 

0.019%

【检查】

 Analysis

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

符合规定

Complies

6S，12aS对映异构体不得过0.1%

6S,12aS enantiomer not more than 0.1%

未检出

Not detected

6S，12aR非对映异构体不得过0.1%

6S,12aR diastereomer not more than 0.1%

未检出

Not detected

残留溶剂

Residual solven

甲胺不得过0.163%

Methylamine not more than0.163% 

未检出

Not detected

符合规定

Complies