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%
113.064456224475484457224466674457804462680.19
213.134435934448654442290.21
单位质量响应值RSD%判断
34170.6033833.130.71数据可信
供试品溶液-2026010311批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1453556-45355684.43077.537.3184.4377.537.31
2445721-44572182.97182.97
3429075-42907579.87379.87
4383301-38330171.35271.35
5386715-38671571.98771.99
6400619-40061974.57674.58
5min1542856-542856101.053100.221.34101.05100.221.34
2545155-545155101.481101.48
3546498-546498101.731101.73
4531704-53170498.97798.98
5530906-53090698.82998.83
6533107-53310799.23899.24
10min1548242-548242102.056101.621.17102.06101.621.17
2549449-549449102.280102.28
3548221-548221102.052102.05
4537573-537573100.070100.07
5553374-553374103.011103.01
6538628-538628100.266100.27
15min1547132-547132101.849101.631.29101.85101.631.29
2549391-549391102.270102.27
3551499-551499102.662102.66
4538426-538426100.229100.23
5553164-553164102.972102.97
6536242-53624299.82299.82
30min1547906-547906101.993101.691.30101.99101.691.30
2548372-548372102.080102.08
3551429-551429102.649102.65
4538431-538431100.229100.23
5554556-554556103.231103.23
6536876-53687699.94099.94
45min1548927-548927102.183101.801.38102.18101.801.37
2551247-551247102.615102.62
3550668-550668102.507102.51
4538918-538918100.320100.32
5555134-555134103.339103.34
6536316-53631699.83699.84
极限1548174-548174102.043101.881.25102.04101.881.25
2549855-549855102.356102.36
3552304-552304102.812102.81
4538867-538867100.311100.31
5555387-555387103.386103.39
6539344-539344100.399100.40
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%
113.064453604449614449114461424459204454590.13
213.134451944451544451740.01
单位质量响应值RSD%判断
34108.6533905.100.43数据可信
供试品溶液-2026010411批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1382276-38227671.14973.485.6171.1573.485.61
2383539-38353971.38571.38
3388455-38845572.29972.30
4437035-43703581.34181.34
5400106-40010674.46874.47
6377247-37724770.21370.21
5min1522022-52202297.15997.920.7197.1697.920.71
2526830-52683098.05498.05
3523840-52384097.49797.50
4525127-52512797.73797.74
5532888-53288899.18199.18
6525953-52595397.89197.89
10min1528778-52877898.41798.720.6498.4298.720.64
2528818-52881898.42498.42
3529916-52991698.62898.63
4528122-52812298.29498.29
5537182-53718299.98199.98
6529673-52967398.58398.58
15min1528277-52827798.32398.981.1698.3298.981.16
2528379-52837998.34298.34
3530400-53040098.71898.72
4529031-52903198.46498.46
5544230-544230101.292101.29
6530538-53053898.74498.74
30min1528775-52877598.41698.930.6998.4298.930.69
2528643-52864398.39198.39
3531004-53100498.83198.83
4530939-53093998.81998.82
5538576-538576100.240100.24
6531325-53132598.89198.89
45min1528224-52822498.31399.000.6898.3199.000.68
2529843-52984398.61598.61
3531731-53173198.96698.97
4531075-53107598.84498.84
5538621-538621100.248100.25
6531944-53194499.00699.01
极限1529888-52988898.62399.941.6598.6299.941.65
2537896-537896100.114100.11
3532079-53207999.03199.03
4553185-553185102.959102.96
5538784-538784100.279100.28
6530099-53009998.66298.66
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%
113.064452644450214455474461974447454453550.13
213.134445194438284441740.12
单位质量响应值RSD%判断
34100.6933828.940.57数据可信
供试品溶液-2026010511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1414560-41456077.25480.005.3277.2580.005.32
2432030-43203080.51080.51
3468714-46871487.34687.35
4416745-41674577.66177.66
5405172-40517275.50575.50
6438514-43851481.71881.72
5min1543063-543063101.201100.910.84101.20100.910.84
2542986-542986101.187101.19
3546030-546030101.754101.75
4541380-541380100.887100.89
5532785-53278599.28699.29
6542635-542635101.121101.12
10min1549843-549843102.465102.241.03102.46102.241.03
2546770-546770101.892101.89
3547651-547651102.056102.06
4559305-559305104.228104.23
5544009-544009101.377101.38
6544351-544351101.441101.44
15min1549346-549346102.372101.990.40102.37101.990.40
2547559-547559102.039102.04
3547598-547598102.046102.05
4545493-545493101.654101.65
5549696-549696102.437102.44
6544070-544070101.389101.39
30min1546190-546190101.784101.770.40101.78101.770.40
2545316-545316101.621101.62
3549840-549840102.464102.46
4547076-547076101.949101.95
5544106-544106101.395101.40
6544143-544143101.402101.40
45min1546717-546717101.882101.950.86101.88101.950.86
2554763-554763103.381103.38
3550318-550318102.553102.55
4544512-544512101.471101.47
5544004-544004101.376101.38
6542288-542288101.057101.06
极限1546442-546442101.831101.530.72101.83101.530.72
2542479-542479101.092101.09
3552142-552142102.893102.89
4543506-543506101.284101.28
5542332-542332101.065101.06
6542171-542171101.035101.03
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%
113.064465634466864468624464254469254466920.05
213.134462684464794463740.04
单位质量响应值RSD%判断
34203.0633996.500.43数据可信
供试品溶液-2026010311批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1421635-42163578.26171.4413.0178.2671.4413.01
2415337-41533777.09277.09
3404662-40466275.11175.11
4423330-42333078.57678.58
5338078-33807862.75262.75
6306242-30624256.84356.84
5min1552282-552282102.511100.081.69102.51100.081.70
2543420-543420100.866100.87
3534233-53423399.16199.16
4537027-53702799.68099.68
5542689-542689100.730100.73
6525612-52561297.56197.56
10min1555837-555837103.171101.461.22103.17101.461.22
2542697-542697100.732100.73
3541786-541786100.563100.56
4543004-543004100.789100.79
5554537-554537102.930102.93
6541971-541971100.597100.60
15min1555347-555347103.080101.691.23103.08101.701.24
2547465-547465101.617101.62
3540684-540684100.358100.36
4542308-542308100.660100.66
5556737-556737103.338103.34
6544757-544757101.114101.11
30min1556850-556850103.359101.851.14103.36101.861.14
2550593-550593102.198102.20
3541029-541029100.422100.42
4543490-543490100.879100.88
5554248-554248102.876102.88
6546248-546248101.391101.39
45min1557847-557847103.544101.761.43103.54101.761.42
2549307-549307101.959101.96
3537075-53707599.68899.69
4543384-543384100.859100.86
5555765-555765103.158103.16
6546060-546060101.356101.36
极限1557947-557947103.563102.001.22103.56102.001.21
2552726-552726102.593102.59
3542724-542724100.737100.74
4543531-543531100.887100.89
5555526-555526103.113103.11
6544764-544764101.116101.12
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%
113.064484184488864493904493764487004489540.10
213.134476354471694474020.08
单位质量响应值RSD%判断
34376.2634074.790.63数据可信
供试品溶液-2026010411批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1400537-40053774.07366.959.8374.0766.949.83
2384528-38452871.11271.11
3365011-36501167.50367.50
4384318-38431871.07371.07
5311789-31178957.66057.66
6325815-32581560.25460.25
5min1525015-52501597.09396.601.3997.0996.601.39
2525821-52582197.24297.24
3519548-51954896.08296.08
4525093-52509397.10797.11
5529498-52949897.92297.92
6509077-50907794.14594.15
10min1533006-53300698.57198.790.8898.5798.790.88
2532407-53240798.46098.46
3541084-541084100.065100.06
4528051-52805197.65497.65
5532437-53243798.46598.47
6538204-53820499.53299.53
15min1531161-53116198.22998.400.6598.2398.390.65
2532975-53297598.56598.56
3532805-53280598.53498.53
4528323-52832397.70597.70
5529153-52915397.85897.86
6537929-53792999.48199.48
30min1533830-53383098.72399.171.1398.7299.171.13
2533583-53358398.67798.68
3533183-53318398.60398.60
4530535-53053598.11498.11
5547071-547071101.172101.17
6539381-53938199.75099.75
45min1531031-53103198.20598.830.5998.2198.830.59
2532121-53212198.40798.41
3533586-53358698.67898.68
4538328-53832899.55599.55
5533152-53315298.59898.60
6538173-53817399.52699.53
极限1552577-552577102.19099.371.50102.1999.371.50
2535522-53552299.03699.04
3536130-53613099.14899.15
4530578-53057898.12298.12
5531087-53108798.21698.22
6537928-53792899.48199.48
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%
113.064463004470594469544470184469684468600.08
213.134462904471404467150.14
单位质量响应值RSD%判断
34215.9334022.470.41数据可信
供试品溶液-2026010511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1424289-42428978.70968.5810.1678.7168.5810.16
2367781-36778168.22668.23
3320647-32064759.48359.48
4356270-35627066.09166.09
5347812-34781264.52264.52
6401336-40133674.45174.45
5min1540363-540363100.24299.721.44100.2499.721.44
2540537-540537100.274100.27
3543580-543580100.838100.84
4544642-544642101.035101.04
5531039-53103998.51298.51
6525189-52518997.42797.43
10min1547271-547271101.523101.561.46101.52101.561.46
2548029-548029101.664101.66
3551985-551985102.398102.40
4555621-555621103.072103.07
5549434-549434101.924101.92
6532444-53244498.77398.77
15min1546785-546785101.433101.551.27101.43101.551.27
2547547-547547101.574101.57
3551871-551871102.376102.38
4554049-554049102.780102.78
5549831-549831101.998102.00
6534440-53444099.14399.14
30min1544695-544695101.045101.431.77101.05101.431.77
2547577-547577101.580101.58
3557337-557337103.390103.39
4552852-552852102.558102.56
5548957-548957101.836101.84
6529175-52917598.16698.17
45min1545067-545067101.114101.311.62101.11101.311.62
2546924-546924101.459101.46
3553737-553737102.723102.72
4550960-550960102.207102.21
5550739-550739102.166102.17
6529259-52925998.18298.18
极限1545594-545594101.212101.241.56101.21101.241.57
2545972-545972101.282101.28
3552362-552362102.467102.47
4549679-549679101.970101.97
5551459-551459102.300102.30
6529302-52930298.19098.19
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