枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182385852385622384442382762383442384420.06
217.062375102374742374920.02
单位质量响应值RSD%判断
13879.0513920.980.22数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1283601-283601103.310101.231.64103.31101.231.64
2275020-275020100.184100.18
3281754-281754102.637102.64
4271570-27157098.92798.93
5275805-275805100.470100.47
6279655-279655101.872101.87
10min1280147-280147102.051101.551.36102.22101.721.36
2275844-275844100.484100.65
3284195-284195103.526103.70
4273625-27362599.67699.84
5277980-277980101.262101.43
6280853-280853102.309102.48
15min1278826-278826101.570101.231.38101.91101.571.37
2274498-27449899.994100.33
3283458-283458103.258103.60
4273270-27327099.54699.88
5276839-276839100.846101.18
6280480-280480102.173102.51
20min1277749-277749101.178100.541.75101.69101.051.75
2275965-275965100.528101.03
3282885-282885103.049103.56
4274270-27427099.911100.41
5277053-277053100.924101.43
6268125-26812597.67298.18
30min1278464-278464101.438100.711.30102.12101.391.30
2273118-27311899.491100.16
3280716-280716102.259102.95
4271659-27165998.95999.62
5275674-275674100.422101.09
6279213-279213101.711102.38
45min1277845-277845101.213100.491.16102.06101.331.16
2273017-27301799.454100.29
3280266-280266102.095102.95
4271483-27148398.89599.72
5276338-276338100.664101.50
6276250-276250100.632101.47
极限1278079-278079101.298100.751.47102.32101.761.46
2273274-27327499.548100.55
3282339-282339102.850103.88
4271404-27140498.86799.86
5275172-275172100.239101.25
6279166-279166101.694102.70
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182382152381022382852382432380202381730.05
217.062371172373122372140.06
单位质量响应值RSD%判断
13863.3913904.690.22数据可信
供试品溶液-2024051611批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278158-278158101.443101.291.91101.44101.281.91
2273855-27385599.87499.87
3287748-287748104.941104.94
4277926-277926101.359101.36
5273514-27351499.75099.75
6275163-275163100.351100.35
10min1281905-281905102.810100.881.67102.98101.051.67
2276456-276456100.823100.99
3278101-278101101.423101.60
4280820-280820102.414102.58
5271102-27110298.87099.04
6271323-27132398.95199.12
15min1280372-280372102.251100.691.77102.59101.021.76
2276008-276008100.659100.99
3278538-278538101.582101.93
4281035-281035102.493102.83
5269388-26938898.24598.58
6271131-27113198.88199.21
20min1279814-279814102.047100.911.41102.56101.421.40
2274546-274546100.126100.63
3276895-276895100.983101.50
4278379-278379101.524102.03
5280495-280495102.296102.79
6270100-27010098.50599.00
30min1278751-278751101.660100.011.76102.34100.681.75
2274159-27415999.985100.65
3276541-276541100.854101.54
4279020-279020101.758102.44
5268463-26846397.90898.57
6268466-26846697.90998.57
45min1279366-279366101.884100.171.88102.73101.001.88
2273049-27304999.580100.42
3280338-280338102.239103.09
4277518-277518101.210102.06
5268589-26858997.95498.78
6269068-26906898.12898.95
极限1281555-281555102.68299.892.04103.70100.892.03
2273199-27319999.635100.64
3275982-275982100.650101.67
4277370-277370101.156102.17
5267163-26716397.43498.43
6268067-26806797.76398.75
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182358402358622359162356692358312358240.04
217.062357342357682357510.02
单位质量响应值RSD%判断
13726.6613818.930.48数据可信
供试品溶液-2024051612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1268482-26848298.70698.971.1298.7198.971.12
2270156-27015699.32299.32
3269001-26900198.89798.90
4271384-27138499.77399.77
5263836-26383696.99897.00
6272380-272380100.139100.14
10min1269593-26959399.11599.791.4199.2899.951.41
2270302-27030299.37699.54
3276771-276771101.754101.92
4271943-27194399.979100.15
5265758-26575897.70597.87
6274136-274136100.785100.95
15min1270033-27003399.27799.501.0299.6199.831.02
2272512-272512100.188100.52
3271692-27169299.887100.22
4268989-26898998.89399.23
5266407-26640797.94498.27
6274155-274155100.792101.13
20min1268469-26846998.70299.301.1599.2099.801.15
2270650-27065099.503100.00
3273495-273495100.549101.05
4270869-27086999.584100.08
5264794-26479497.35197.84
6272268-272268100.098100.60
30min1268057-26805798.55099.220.8699.2199.880.86
2270489-27048999.444100.11
3270919-27091999.602100.27
4270646-27064699.502100.17
5266327-26632797.91498.56
6272797-272797100.293100.96
45min1268826-26882698.83399.251.1699.66100.081.16
2270285-27028599.369100.20
3270676-27067699.513100.35
4272195-272195100.071100.90
5264469-26446997.23198.04
6273332-273332100.489101.33
极限1270525-27052599.45899.341.12100.45100.341.12
2269856-26985699.212100.21
3272413-272413100.152101.15
4271796-27179699.925100.92
5264406-26440697.20898.18
6272312-272312100.114101.12
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182366532360162362612362302367482363820.14
217.062389432388122388780.04
单位质量响应值RSD%判断
13759.1414002.231.24数据可信
供试品溶液-2024051612批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1264278-26427896.41297.631.5696.4197.621.56
2268506-26850697.95497.95
3262037-26203795.59495.59
4271845-27184599.17299.17
5266477-26647797.21497.21
6272493-27249399.40999.41
10min1268500-26850097.95298.751.1098.1198.911.10
2268312-26831297.88498.05
3267530-26753097.59897.76
4274384-274384100.099100.26
5271702-27170299.12099.28
6273621-27362199.82099.99
15min1263962-26396296.29798.321.1596.6298.641.15
2270261-27026198.59598.92
3268458-26845897.93798.26
4272393-27239399.37299.70
5269730-26973098.40198.73
6272162-27216299.28899.62
20min1267218-26721897.48598.050.8697.9798.540.85
2269788-26978898.42298.91
3267240-26724097.49397.98
4271997-27199799.22899.73
5266047-26604797.05797.55
6270351-27035198.62799.12
30min1267290-26729097.51198.191.1498.1698.841.14
2267030-26703097.41698.07
3266635-26663597.27297.92
4274791-274791100.247100.91
5269908-26990898.46699.12
6269184-26918498.20298.86
45min1266346-26634697.16698.471.0397.9899.291.02
2272567-27256799.436100.25
3267112-26711297.44698.26
4271720-27172099.12799.96
5269249-26924998.22599.04
6272486-27248699.406100.23
极限1269090-26909098.16798.061.2399.1499.041.22
2267276-26727697.50698.49
3263517-26351796.13497.11
4272518-27251899.418100.41
5268500-26850097.95298.93
6271889-27188999.189100.18
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182371542374942373412373372375902373830.08
217.062378892379802379340.03
单位质量响应值RSD%判断
13817.4013946.890.66数据可信
供试品溶液-2024051613批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1276809-276809100.967100.421.90100.97100.421.91
2280758-280758102.408102.41
3280179-280179102.196102.20
4270356-27035698.61398.61
5275986-275986100.667100.67
6267817-26781797.68797.69
10min1271700-27170099.104100.791.6699.27100.961.66
2281849-281849102.806102.98
3282181-282181102.927103.10
4273912-27391299.911100.07
5275306-275306100.419100.59
6272994-27299499.57699.74
15min1273400-27340099.724100.831.31100.06101.171.32
2279490-279490101.945102.29
3282341-282341102.985103.33
4274945-274945100.287100.62
5274503-274503100.126100.46
6273982-27398299.936100.26
20min1272582-27258299.425101.182.2699.93101.692.26
2281001-281001102.496103.01
3288351-288351105.177105.69
4274364-274364100.075100.57
5276047-276047100.689101.19
6272072-27207299.23999.73
30min1271343-27134398.973100.561.7699.64101.231.76
2282919-282919103.196103.88
3280065-280065102.155102.84
4271268-27126898.94699.61
5275590-275590100.523101.19
6272961-27296199.564100.22
45min1271258-27125898.942100.481.6499.77101.321.63
2280786-280786102.418103.27
3280780-280780102.416103.27
4271914-27191499.182100.01
5276295-276295100.780101.62
6271795-27179599.13899.97
极限1272357-27235799.343100.141.49100.34101.141.49
2279713-279713102.026103.05
3278473-278473101.574102.60
4271777-27177799.132100.13
5275600-275600100.526101.53
6269277-26927798.22099.21
枸橼酸西地那非片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号420012-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.8对照品水分(%)0对照品稀释倍数500
标示量(mg)25供试品稀释倍数1系数0.7118
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.182349032352262352282350432352232351250.07
217.062353032352302352660.03
单位质量响应值RSD%判断
13685.9713790.500.54数据可信
供试品溶液-2024051613批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1260573-26057396.04099.081.6396.0499.081.63
2269661-26966199.39099.39
3271078-27107899.91299.91
4268205-26820598.85398.85
5273293-273293100.728100.73
6270085-27008599.54699.55
10min1263615-26361597.161100.291.7497.32100.461.74
2272849-272849100.565100.73
3271877-271877100.206100.37
4273598-273598100.841101.01
5278164-278164102.524102.69
6272527-272527100.446100.61
15min1264054-26405497.32399.951.4197.64100.281.41
2272597-272597100.472100.80
3272040-272040100.266100.60
4271694-271694100.139100.47
5275470-275470101.531101.87
6271272-27127299.983100.32
20min1264216-26421697.38399.911.4397.87100.411.43
2272530-272530100.447100.95
3271109-27110999.923100.42
4270885-27088599.841100.34
5276076-276076101.754102.26
6271671-271671100.130100.63
30min1264967-26496797.65999.761.2198.31100.431.21
2270137-27013799.565100.23
3270795-27079599.808100.47
4271894-271894100.213100.88
5275008-275008101.360102.04
6271277-27127799.985100.65
45min1264903-26490397.63699.651.1498.45100.491.14
2269353-26935399.276100.11
3272095-272095100.287101.12
4270124-27012499.560100.39
5273164-273164100.681101.53
6272636-272636100.486101.32
极限1271120-27112099.927100.110.68100.90101.110.68
2270180-27018099.581100.58
3269672-26967299.394100.39
4271164-27116499.944100.94
5274459-274459101.158102.17
6273128-273128100.667101.67
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