中文名称:他达那非
中文别名:西力士;他地那非;
英文名称:Tildenafil
英文别名:Cialis;
(6R,12aR)-6-(benzo[d][1,3]dioxol-5-yl)-2-methyl-2,3,12,12a tetrahydropyrazino [1',2':1,6] pyrido[3,4b] indole1,4(6H,7H)-dione;
(6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6] pyrido[3,4-b]indole-1,4-dione;
CAS号:171596-29-5
分子式:C22H19N3O4
分子量:389.40400
精确质量:389.13800
PSA:74.87000
LogP:2.08710
物化性质
外观与性状:白色或类白色粉末
密度:1.51 g/cm3
熔点:298-300?C
沸点:679.1?C at 760 mmHg
闪点:364.5?C
折射率:1.705
蒸汽压:5.29E-13mmHg at 25°C
白色或类白色粉末White or almost white crystalline powder
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
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
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%
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%
乙酸甲酯≤0.5%
Methyl acetate≤0.5%
98% ~ 102.0 % (干品计dried substance).
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.