枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064476324474444488054469734473654476440.16
213.134471464469394470420.04
单位质量响应值RSD%判断
34275.9634047.370.48数据可信
供试品溶液-2026010311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%
2min1415867-41586777.05177.014.6677.0577.014.66
2401735-40173574.43374.43
3386281-38628171.56971.57
4432370-43237080.10980.11
5438512-43851281.24781.25
6419038-41903877.63877.64
5min1510363-51036394.55997.992.3694.5697.992.36
2520859-52085996.50496.50
3540942-540942100.225100.22
4540028-540028100.055100.06
5523755-52375597.04097.04
6537404-53740499.56999.57
10min1537427-53742799.573100.330.9399.57100.330.93
2541870-541870100.396100.40
3549910-549910101.886101.89
4543444-543444100.688100.69
5535740-53574099.26199.26
6540539-540539100.150100.15
15min1537766-53776699.636100.480.8899.64100.480.89
2544640-544640100.910100.91
3550562-550562102.007102.01
4542221-542221100.461100.46
5538297-53829799.73499.73
6540460-540460100.135100.14
30min1538465-53846599.766100.560.8999.77100.560.89
2542323-542323100.480100.48
3551833-551833102.242102.24
4542806-542806100.570100.57
5538993-53899399.86399.86
6541961-541961100.413100.41
45min1539239-53923999.909100.750.8899.91100.750.88
2546127-546127101.185101.19
3551853-551853102.246102.25
4543824-543824100.758100.76
5539276-53927699.91699.92
6542269-542269100.470100.47
极限1540786-540786100.196100.680.88100.20100.680.88
2544727-544727100.926100.93
3552269-552269102.323102.32
4541932-541932100.408100.41
5538634-53863499.79799.80
6542099-542099100.439100.44
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064489444484524481694497004485864487700.14
213.134467024466524466770.01
单位质量响应值RSD%判断
34362.1734019.570.71数据可信
供试品溶液-2026010411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%
2min1445064-44506482.39181.793.8582.3981.783.85
2451980-45198083.67183.67
3461189-46118985.37685.38
4429418-42941879.49579.49
5414362-41436276.70876.71
6448729-44872983.07083.07
5min1548327-548327101.507100.171.05101.51100.171.05
2544962-544962100.884100.88
3544965-544965100.885100.89
4536050-53605099.23599.23
5534809-53480999.00599.00
6537537-53753799.51099.51
10min1551284-551284102.055100.711.03102.05100.711.03
2547360-547360101.328101.33
3546146-546146101.104101.10
4542142-542142100.362100.36
5535030-53503099.04699.05
6542176-542176100.369100.37
15min1553263-553263102.421100.581.25102.42100.581.25
2547973-547973101.442101.44
3544818-544818100.858100.86
4539696-53969699.91099.91
5534372-53437298.92498.92
6539830-53983099.93499.93
30min1550438-550438101.898100.611.06101.90100.611.06
2547981-547981101.443101.44
3545330-545330100.953100.95
4541818-541818100.302100.30
5534326-53432698.91698.92
6541060-541060100.162100.16
45min1548317-548317101.506100.270.89101.51100.270.89
2543815-543815100.672100.67
3542911-542911100.505100.50
4540075-54007599.98099.98
5533863-53386398.83098.83
6540909-540909100.134100.13
极限1548982-548982101.629100.251.08101.63100.261.08
2545042-545042100.899100.90
3544701-544701100.836100.84
4537643-53764399.53099.53
5532866-53286698.64598.65
6540090-54009099.98399.98
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064455124465064467174468704476824466570.18
213.134474254475514474880.02
单位质量响应值RSD%判断
34200.3834081.340.25数据可信
供试品溶液-2026010511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%
2min1432919-43291980.25879.083.3080.2679.083.30
2425409-42540978.86678.87
3402832-40283274.68174.68
4444965-44496582.49282.49
5421864-42186478.20978.21
6431229-43122979.94579.95
5min1537704-53770499.68499.330.8899.6899.330.88
2537232-53723299.59799.60
3537855-53785599.71299.71
4529303-52930398.12798.13
5530923-53092398.42798.43
6541629-541629100.412100.41
10min1542016-542016100.48499.951.05100.4899.951.05
2540176-540176100.143100.14
3542368-542368100.549100.55
4531842-53184298.59898.60
5532621-53262198.74298.74
6545739-545739101.174101.17
15min1541651-541651100.41699.870.89100.4299.870.89
2541312-541312100.353100.35
3542096-542096100.499100.50
4532237-53223798.67198.67
5532876-53287698.78998.79
6541917-541917100.466100.47
30min1540724-540724100.24499.900.91100.2499.900.91
2540479-540479100.199100.20
3542049-542049100.490100.49
4532251-53225198.67498.67
5533530-53353098.91198.91
6544322-544322100.911100.91
45min1540706-540706100.24199.910.93100.2499.910.93
2540742-540742100.248100.25
3544378-544378100.922100.92
4532306-53230698.68498.68
5533263-53326398.86198.86
6542218-542218100.521100.52
极限1541433-541433100.37699.900.98100.3899.900.98
2540912-540912100.279100.28
3542525-542525100.578100.58
4531870-53187098.60398.60
5532553-53255398.73098.73
6543777-543777100.810100.81
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064488954484414490294480224488194486410.10
213.134485394476604481000.14
单位质量响应值RSD%判断
34352.3034127.950.47数据可信
供试品溶液-2026010311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%
2min1422390-42239078.08078.673.1278.0878.673.12
2424299-42429978.43378.43
3432427-43242779.93579.94
4404730-40473074.81674.82
5424499-42449978.47078.47
6445235-44523582.30382.30
5min1539308-53930899.69399.130.6199.6999.130.61
2537382-53738299.33799.34
3534864-53486498.87198.87
4532063-53206398.35498.35
5540285-54028599.87399.87
6533657-53365798.64898.65
10min1542526-542526100.28899.510.99100.2999.511.00
2541216-541216100.045100.05
3538733-53873399.58699.59
4536396-53639699.15499.15
5542360-542360100.257100.26
6528552-52855297.70497.70
15min1540954-54095499.99799.470.76100.0099.470.76
2541416-541416100.082100.08
3540006-54000699.82299.82
4536688-53668899.20899.21
5539145-53914599.66399.66
6530512-53051298.06798.07
30min1542103-542103100.20999.600.63100.2199.600.64
2539992-53999299.81999.82
3538127-53812799.47499.47
4534600-53460098.82298.82
5542679-542679100.316100.32
6535349-53534998.96198.96
45min1540369-54036999.88999.570.6599.8999.580.64
2540283-54028399.87399.87
3539501-53950199.72899.73
4535163-53516398.92798.93
5542874-542874100.352100.35
6533827-53382798.68098.68
极限1546251-546251100.97699.760.90100.9899.760.90
2541610-541610100.118100.12
3538075-53807599.46599.46
4534066-53406698.72498.72
5543218-543218100.416100.42
6534907-53490798.87998.88
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064491054483934496634487644480414487930.15
213.134502504490224496360.20
单位质量响应值RSD%判断
34363.9434244.940.25数据可信
供试品溶液-2026010411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%
2min1421268-42126877.72677.765.9677.7377.765.96
2400558-40055873.90573.91
3384367-38436770.91870.92
4444088-44408881.93781.94
5449194-44919482.87982.88
6429235-42923579.19679.20
5min1558705-558705103.084102.150.63103.08102.150.63
2552961-552961102.024102.02
3549745-549745101.431101.43
4556917-556917102.754102.75
5552742-552742101.984101.98
6550921-550921101.648101.65
10min1561614-561614103.621102.880.71103.62102.880.71
2555839-555839102.555102.56
3560507-560507103.416103.42
4561047-561047103.516103.52
5552356-552356101.913101.91
6554344-554344102.279102.28
15min1556755-556755102.724102.970.50102.72102.970.50
2557907-557907102.937102.94
3561546-561546103.608103.61
4560815-560815103.473103.47
5557519-557519102.865102.87
6553985-553985102.213102.21
30min1557671-557671102.893102.400.50102.89102.400.51
2553428-553428102.110102.11
3550896-550896101.643101.64
4557519-557519102.865102.87
5556883-556883102.748102.75
6553544-553544102.132102.13
45min1557476-557476102.857102.230.69102.86102.240.68
2551201-551201101.699101.70
3549739-549739101.430101.43
4559631-559631103.255103.25
5553680-553680102.157102.16
6552878-552878102.009102.01
极限1559174-559174103.170102.690.69103.17102.690.68
2555289-555289102.454102.45
3553785-553785102.176102.18
4560947-560947103.498103.50
5559076-559076103.152103.15
6551073-551073101.676101.68
枸橼酸西地那非口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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200
标示量(mg)50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%
113.064483034485714497364504334489484491980.20
213.134483994485314484650.03
单位质量响应值RSD%判断
34394.9534155.750.50数据可信
供试品溶液-2026010511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%
2min1444080-44408082.00576.529.9082.0176.529.90
2414929-41492976.62276.62
3358468-35846866.19666.20
4460781-46078185.08985.09
5435834-43583480.48380.48
6372102-37210268.71468.71
5min1528715-52871597.63499.891.4697.6399.891.46
2534077-53407798.62498.62
3545052-545052100.651100.65
4542192-542192100.123100.12
5547744-547744101.148101.15
6547922-547922101.181101.18
10min1531401-53140198.130100.811.5298.13100.811.52
2544643-544643100.576100.58
3554994-554994102.487102.49
4543761-543761100.413100.41
5548751-548751101.334101.33
6551910-551910101.918101.92
15min1531302-53130298.112100.961.6198.11100.961.61
2543294-543294100.327100.33
3554356-554356102.369102.37
4545597-545597100.752100.75
5551703-551703101.879101.88
6553940-553940102.292102.29
30min1532799-53279998.388100.961.4998.39100.961.49
2544451-544451100.540100.54
3554922-554922102.474102.47
4544571-544571100.562100.56
5550212-550212101.604101.60
6553490-553490102.209102.21
45min1531766-53176698.198100.861.6798.20100.861.67
2542193-542193100.123100.12
3556149-556149102.700102.70
4542255-542255100.135100.13
5551415-551415101.826101.83
6553167-553167102.150102.15
极限1533028-53302898.431100.961.6998.43100.961.69
2538593-53859399.45899.46
3557447-557447102.940102.94
4547317-547317101.069101.07
5553018-553018102.122102.12
6550931-550931101.737101.74
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