中文名稱：他達(dá)那非
中文別名：西力士;他地那非;
英文名稱：Tildenafil
英文別名：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號(hào)：171596-29-5
分子式：C22H19N3O4
分子量：389.40400
精確質(zhì)量：389.13800
PSA：74.87000
LogP：2.08710
物化性質(zhì)
外觀與性狀：白色或類白色粉末
密度：1.51 g/cm3
熔點(diǎn)：298-300?C
沸點(diǎn)：679.1?C at 760 mmHg
閃點(diǎn)：364.5?C
折射率：1.705
蒸汽壓：5.29E-13mmHg at 25°C
分析項(xiàng)目
ITEM OF ANALYSIS
白色或類白色粉末White or almost white crystalline powder
幾乎不溶于水,易溶于二甲亞砜,微溶于二氯甲烷
Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride
紅外圖譜與參照?qǐng)D譜一致
The infrared absorption spectrum is concordant with the reference spectrum
供試品溶液中主峰的保留時(shí)間應(yīng)與鑒別溶液中主峰的保留時(shí)間一致
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
雜質(zhì)A,B,C
Impurities A, B and C
雜質(zhì) A, B and C≤0.1%
Impurity A, B and C≤0.1%
熾灼殘?jiān)?/strong>
Residue on ignition
有關(guān)物質(zhì)（HPLC）
Related substances
單項(xiàng)雜質(zhì)≤0.1%
Individual impurity≤0.1%
總雜質(zhì)≤0.3%
Total unknown impurity≤0.3%
乙酸甲酯≤0.5%
Methyl acetate≤0.5%
98% ~ 102.0 % (干品計(jì)dried substance).
本品按EP 9/USP40標(biāo)準(zhǔn)檢驗(yàn)，結(jié)果符合規(guī)定。
The test results conform with EP 9/USP40 Specification.