他达那非

分析项目

ITEM OF ANALYSIS

标准

STANDARD

性状Appearance

白色或类白色粉末White or almost white crystalline powder

溶解度

Solubility

几乎不溶于水,易溶于二甲亚砜,微溶于二氯甲烷

Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride

熔点

Melting point

302℃~303℃

鉴别

Identification

红外图谱与参照图谱一致

The infrared absorption spectrum is concordant with the reference spectrum

供试品溶液中主峰的保留时间应与鉴别溶液中主峰的保留时间一致

The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution

比旋度

Rotation

+ 78.0°to + 84.0°

杂质A,B,C

Impurities A, B and C

杂质 A, B and C≤0.1%

Impurity  A, B and C≤0.1%

干燥失重

Loss on drying

≤0.5%

炽灼残渣

Residue on ignition

≤0.1%

重金属

Heavy metals

≤10ppm

有关物质（HPLC）

Related substances

单项杂质≤0.1%

Individual impurity≤0.1%

总杂质≤0.3%

Total unknown impurity≤0.3%

残留溶剂

Residual Solvents

甲醇≤0.3%

Methanol;≤0.3%

乙酸乙酯≤0.5%

EA≤0.5%

异丙醇≤0.5%

IPA≤0.5%

乙酸甲酯≤0.5%

Methyl acetate≤0.5%

二氯甲烷≤0.06%

DCM≤0.06%

醋酸≤0.5%

AceticAcid≤0.5%

含量Assay

98% ~ 102.0 % (干品计dried substance).

结论

Conclusion

本品按EP 9/USP40标准检验，结果符合规定。

The test results conform with EP 9/USP40 Specification.