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%
117.189459669459249456079451509446499454590.06
217.069457469460679459060.03
单位质量响应值RSD%判断
55032.5455445.840.53数据可信
每杯投4片--供试品溶液-2024051611批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1569619-56961952.21456.179.5752.2156.179.58
2655943-65594360.12760.13
3519289-51928947.60147.60
4669224-66922461.34561.34
5610430-61043055.95555.96
6651902-65190259.75759.76
10min1605207-60520755.47759.223.6455.5659.313.63
2653488-65348859.90260.00
3672387-67238761.63561.71
4662627-66262760.74060.84
5638620-63862058.53958.63
6643688-64368859.00459.10
15min1605913-60591355.54158.993.5555.7259.183.54
2655653-65565360.10160.30
3663402-66340260.81160.99
4660119-66011960.51060.71
5625798-62579857.36457.55
6650569-65056959.63559.83
20min1603171-60317155.29058.403.1455.5658.693.14
2650342-65034259.61459.91
3654539-65453959.99960.28
4648021-64802159.40159.71
5622899-62289957.09857.38
6643908-64390859.02459.32
30min1594579-59457954.50256.465.1854.8756.855.15
2635955-63595558.29558.69
3649785-64978559.56359.95
4637155-63715558.40558.81
5613537-61353756.24056.62
6564715-56471551.76552.16
45min1582448-58244853.39056.143.0553.8556.623.04
2618956-61895656.73757.23
3634002-63400258.11658.60
4621697-62169756.98857.49
5598375-59837554.85055.33
6619186-61918656.75857.24
极限1549594-54959450.37952.342.6650.9252.912.66
2579116-57911653.08553.68
3589380-58938054.02654.61
4582758-58275853.41954.01
5562399-56239951.55352.12
6562506-56250651.56252.14
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%
117.189431609431559434799438839438579435070.04
217.069427489421979424720.05
单位质量响应值RSD%判断
54918.9255244.550.42数据可信
每杯投4片--供试品溶液-2024051612批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1599453-59945355.10656.502.2355.1156.502.24
2637750-63775058.62758.63
3608359-60835955.92555.92
4605336-60533655.64755.65
5614980-61498056.53356.53
6621545-62154557.13757.14
10min1589893-58989354.22756.312.3054.3256.402.30
2624173-62417357.37857.48
3625014-62501457.45657.55
4601084-60108455.25655.35
5616981-61698156.71756.81
6618195-61819556.82956.92
15min1576775-57677553.02155.682.9753.2055.862.97
2615104-61510456.54556.74
3618581-61858156.86457.05
4590004-59000454.23754.42
5612425-61242556.29856.49
6620980-62098057.08557.27
20min1571809-57180952.56554.652.5352.8454.932.52
2604690-60469055.58755.87
3612432-61243256.29956.58
4582222-58222253.52253.80
5595225-59522554.71755.00
6600449-60044955.19855.48
30min1571245-57124552.51353.522.3052.8753.892.30
2595436-59543654.73755.12
3599380-59938055.09955.48
4571072-57107252.49752.86
5586488-58648853.91454.29
6569570-56957052.35952.74
45min1571020-57102052.49251.823.3852.9452.283.35
2583125-58312553.60554.08
3530743-53074348.79049.26
4556540-55654051.16151.61
5561851-56185151.64952.11
6579168-57916853.24153.71
极限1538346-53834649.48949.321.8650.0249.871.85
2546425-54642550.23150.79
3526907-52690748.43748.99
4522337-52233748.01748.55
5538846-53884649.53550.08
6546275-54627550.21750.77
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%
117.189439359437589433419439579436769437330.03
217.069402699403879403280.01
单位质量响应值RSD%判断
54932.0755118.870.25数据可信
每杯投4片--供试品溶液-2024051613批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1544495-54449550.10547.9812.3250.1047.9812.32
2578857-57885753.26753.27
3396628-39662836.49836.50
4518182-51818247.68347.68
5551286-55128650.73050.73
6539077-53907749.60649.61
10min1521783-52178348.01549.766.0148.1049.846.02
2582803-58280353.63053.72
3493780-49378045.43845.50
4527254-52725448.51848.60
5565203-56520352.01052.09
6553504-55350450.93451.02
15min1542302-54230249.90350.653.1150.0750.813.11
2577175-57717553.11253.29
3551426-55142650.74350.88
4524901-52490148.30248.46
5555222-55522251.09251.26
6551454-55145450.74550.91
20min1525983-52598348.40149.583.6948.6549.833.68
2576130-57613053.01653.28
3543865-54386550.04750.27
4521173-52117347.95948.20
5533763-53376349.11749.37
6531843-53184348.94049.19
30min1491065-49106545.18848.654.4745.5248.984.45
2562085-56208551.72352.08
3532737-53273749.02349.33
4516567-51656747.53547.86
5537285-53728549.44149.78
6532370-53237048.98949.32
45min1515870-51587047.47147.891.4047.8748.301.39
2518218-51821847.68748.13
3526233-52623348.42448.81
4509162-50916246.85347.25
5527654-52765448.55548.98
6525257-52525748.33448.75
极限1490658-49065845.15145.742.2445.6346.222.25
2515640-51564047.44947.97
3494859-49485945.53746.00
4482522-48252244.40244.88
5497476-49747645.77846.28
6500965-50096546.09946.59
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