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125
标示量(mg)100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%
117.901962121960581962031957201964151961220.14
217.711959671966871963270.26
单位质量响应值RSD%判断
10956.5411085.660.83数据可信
供试品溶液-2022072501批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218618-218618100.44499.181.31100.4499.181.30
2214035-21403598.33898.34
3211578-21157897.20997.21
4218067-218067100.191100.19
5214965-21496598.76598.77
6217966-217966100.144100.14
10min1219658-219658100.92299.871.28101.09100.041.28
2213883-21388398.26898.43
3215616-21561699.06599.23
4218468-218468100.375100.54
5215537-21553799.02899.19
6221059-221059101.565101.73
15min1220142-220142101.14499.791.14101.48100.131.14
2214599-21459998.59798.93
3214676-21467698.63398.96
4218653-218653100.460100.79
5215797-21579799.14899.48
6219354-219354100.782101.12
20min1220848-220848101.46899.571.31101.97100.071.31
2213919-21391998.28598.78
3214257-21425798.44098.93
4217083-21708399.739100.24
5215028-21502898.79499.29
6219154-219154100.690101.19
30min1218722-218722100.49299.321.09101.1699.991.09
2213148-21314897.93198.59
3214101-21410198.36999.02
4217348-21734899.860100.53
5215298-21529898.91899.58
6218478-218478100.380101.05
45min1218496-218496100.38899.621.00101.23100.460.99
2218869-218869100.559101.38
3213333-21333398.01698.84
4216157-21615799.313100.15
5215743-21574399.12399.95
6218388-218388100.338101.18
极限1218096-218096100.20498.771.27101.2199.761.27
2211501-21150197.17498.16
3212762-21276297.75398.74
4215888-21588899.190100.19
5213780-21378098.22199.21
6217789-217789100.063101.07
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125
标示量(mg)100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%
117.901963811964681967651961551963711964280.12
217.711960621965731963180.19
单位质量响应值RSD%判断
10973.6311085.150.72数据可信
供试品溶液-2022072501批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1214805-21480598.61798.751.0698.6298.761.06
2216264-21626499.28799.29
3212990-21299097.78497.78
4212001-21200197.33097.33
5217924-217924100.049100.05
6216638-21663899.45899.46
10min1216601-21660199.44199.631.1199.6199.801.11
2217447-21744799.830100.00
3214363-21436398.41498.58
4214450-21445098.45498.62
5220390-220390101.181101.35
6218799-218799100.451100.62
15min1215601-21560198.98299.561.0899.3199.891.08
2218487-218487100.307100.64
3214796-21479698.61398.94
4214125-21412598.30598.63
5219923-219923100.967101.30
6218188-218188100.170100.50
20min1216512-21651299.40199.260.9299.9099.760.92
2217637-21763799.917100.42
3213112-21311297.84098.33
4214455-21445598.45698.95
5217851-217851100.015100.52
6217631-21763199.914100.41
30min1214608-21460898.52699.021.1999.1999.681.19
2217525-21752599.866100.53
3212945-21294597.76398.42
4212754-21275497.67598.33
5218375-218375100.256100.93
6217902-217902100.039100.71
45min1215044-21504498.72799.191.3499.55100.011.33
2217687-21768799.940100.77
3212767-21276797.68198.50
4212871-21287197.72998.55
5218906-218906100.500101.34
6218993-218993100.540101.37
极限1215117-21511798.76099.000.9799.7599.990.97
2216983-21698399.617100.62
3213002-21300297.78998.77
4213456-21345697.99898.98
5217834-217834100.008101.01
6217384-21738499.801100.80
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125
标示量(mg)100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%
117.901958651965791963171958731966661962600.20
217.711962461967201964830.18
单位质量响应值RSD%判断
10964.2511094.470.84数据可信
供试品溶液-B514807批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1212395-21239597.51298.132.2897.5198.142.28
2214236-21423698.35798.36
3218921-218921100.508100.51
4205681-20568194.42994.43
5212671-21267197.63897.64
6218601-218601100.361100.36
10min1214211-21421198.34599.012.2598.5199.172.25
2216052-21605299.19199.35
3220142-220142101.068101.24
4207711-20771195.36195.52
5214648-21464898.54698.71
6221166-221166101.539101.71
15min1213811-21381198.16299.112.4398.4999.442.43
2216284-21628499.29799.63
3221414-221414101.652101.99
4207703-20770395.35895.67
5214449-21444998.45598.78
6221583-221583101.730102.07
20min1213120-21312097.84598.732.3198.3399.222.31
2214945-21494598.68299.18
3220152-220152101.073101.58
4207209-20720995.13195.61
5214257-21425798.36798.86
6220606-220606101.281101.79
30min1211867-21186797.26998.622.1797.9299.282.18
2214955-21495598.68799.35
3219724-219724100.876101.55
4207814-20781495.40996.04
5214527-21452798.49199.15
6219972-219972100.990101.67
45min1213108-21310897.83998.342.2598.6599.172.25
2215099-21509998.75399.58
3218825-218825100.464101.31
4206357-20635794.74095.53
5212418-21241897.52298.34
6219439-219439100.746101.59
极限1211250-21125096.98698.122.2997.9699.112.29
2214434-21443498.44899.44
3217964-217964100.068101.08
4206271-20627194.70095.65
5212519-21251997.56998.55
6219882-219882100.949101.96
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125
标示量(mg)100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%
117.901956081961931963461956691964671960570.21
217.711963411960721962060.10
单位质量响应值RSD%判断
10952.9111078.830.81数据可信
供试品溶液-B514807批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208654-20865495.91196.370.8195.9196.370.81
2211214-21121497.08897.09
3207216-20721695.25095.25
4211570-21157097.25297.25
5210418-21041896.72296.72
6208817-20881795.98695.99
10min1210572-21057296.79397.260.7496.9597.420.74
2212993-21299397.90698.07
3209710-20971096.39796.56
4212682-21268297.76397.92
5213238-21323898.01898.18
6210279-21027996.65896.82
15min1210443-21044396.73497.100.6897.0597.420.68
2212313-21231397.59397.92
3209513-20951396.30696.63
4212559-21255997.70698.03
5212694-21269497.76898.09
6209950-20995096.50796.83
20min1210498-21049896.75996.970.8697.2497.450.86
2213013-21301397.91598.40
3208284-20828495.74196.22
4212513-21251397.68598.17
5211796-21179697.35697.84
6209646-20964696.36796.85
30min1209191-20919196.15896.620.7496.8097.260.74
2211443-21144397.19397.84
3208341-20834195.76796.41
4211885-21188597.39698.05
5211386-21138697.16797.82
6208885-20888596.01796.66
45min1208995-20899596.06896.390.7796.8797.200.77
2210541-21054196.77997.59
3207722-20772295.48396.28
4210930-21093096.95797.77
5211736-21173697.32898.14
6208286-20828695.74296.54
极限1207856-20785695.54496.100.7296.5197.060.72
2210121-21012196.58697.56
3207610-20761095.43196.39
4210460-21046096.74197.72
5210632-21063296.82197.79
6207678-20767895.46396.42
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