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%
117.364737944734824742704738564734034737610.08
217.314726534736174731350.15
单位质量响应值RSD%判断
27290.3827333.040.12数据可信
供试品溶液-2024051711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%
5min1513888-51388895.27297.041.5695.2797.041.56
2531557-53155798.54898.55
3522526-52252696.87496.87
4525651-52565197.45397.45
5532671-53267198.75598.75
6514316-51431695.35295.35
10min1535293-53529399.241100.170.8099.40100.340.80
2542426-542426100.563100.73
3538342-53834299.80699.97
4544931-544931101.028101.19
5544802-544802101.004101.17
6536081-53608199.38799.55
15min1536584-53658499.480100.510.9499.80100.840.94
2542329-542329100.545100.88
3539741-539741100.065100.39
4544808-544808101.005101.34
5550657-550657102.089102.42
6538664-53866499.866100.19
20min1536627-53662799.488100.320.6499.98100.820.64
2542003-542003100.485100.98
3538492-53849299.834100.33
4544912-544912101.024101.52
5545032-545032101.046101.55
6539734-539734100.064100.56
30min1534913-53491399.170100.150.7199.83100.810.71
2540533-540533100.212100.88
3537049-53704999.566100.23
4544773-544773100.998101.67
5543934-543934100.843101.51
6539929-539929100.100100.76
45min1534417-53441799.078100.501.2599.90101.331.25
2553043-553043102.532103.37
3536980-53698099.554100.38
4544295-544295100.910101.75
5544841-544841101.011101.85
6538958-53895899.920100.74
极限1532938-53293898.80499.820.7899.79100.820.78
2537955-53795599.734100.74
3534924-53492499.172100.17
4543863-543863100.830101.83
5542257-542257100.532101.54
6538585-53858599.851100.84
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%
117.364736884731934726004732494733214732100.09
217.314742744725684734210.26
单位质量响应值RSD%判断
27258.6427349.570.24数据可信
供试品溶液-2024051711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%
5min1510861-51086194.73886.9711.5694.7486.9711.56
2485344-48534490.00690.01
3496613-49661392.09692.10
4364142-36414267.52967.53
5497358-49735892.23492.23
6459387-45938785.19285.19
10min1535847-53584799.37196.793.2799.5396.933.28
2534201-53420199.06699.22
3525000-52500097.36097.51
4489281-48928190.73690.85
5527329-52732997.79297.95
6519825-51982596.40096.54
15min1539499-539499100.04998.791.25100.3799.091.26
2541110-541110100.347100.66
3527186-52718697.76598.08
4530536-53053698.38798.65
5533435-53343598.92499.24
6524389-52438997.24797.55
20min1541507-541507100.42199.171.18100.9199.641.18
2541923-541923100.498100.98
3529029-52902998.10798.59
4534812-53481299.17999.61
5534562-53456299.13399.61
6526580-52658097.65398.12
30min1541306-541306100.38499.591.55101.04100.221.55
2546376-546376101.324101.97
3529462-52946298.18798.83
4535270-53527099.26499.86
5544074-544074100.897101.54
6525670-52567097.48498.11
45min1539942-539942100.13199.011.11100.9699.811.11
2540729-540729100.277101.10
3528166-52816697.94798.75
4534858-53485899.18899.95
5533079-53307998.85899.67
6526490-52649097.63698.43
极限1537599-53759999.69698.741.12100.6999.711.12
2540291-540291100.196101.18
3527232-52723297.77498.74
4533590-53359098.95399.88
5531346-53134698.53799.52
6524702-52470297.30598.26
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%
117.364743824737594752364731144742234741430.17
217.314727814723744725780.07
单位质量响应值RSD%判断
27312.3827300.870.03数据可信
供试品溶液-2024051711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%
5min1524184-52418497.19997.030.3797.2097.030.37
2524105-52410597.18597.18
3520156-52015696.45296.45
4524625-52462597.28197.28
5521778-52177896.75396.75
6524872-52487297.32797.33
10min1534319-53431999.07998.890.2599.2499.050.25
2533466-53346698.92099.08
3530877-53087798.44098.60
4533039-53303998.84199.00
5533783-53378398.97999.14
6534390-53439099.09299.25
15min1535344-53534499.26998.620.4399.6098.940.43
2533027-53302798.83999.17
3530347-53034798.34298.67
4528685-52868598.03498.36
5531751-53175198.60298.93
6531771-53177198.60698.93
20min1528692-52869298.03598.691.7298.5399.181.71
2530733-53073398.41498.91
3527470-52747097.80998.30
4524910-52491097.33497.82
5550250-550250102.033102.52
6531269-53126998.51399.00
30min1527429-52742997.80197.790.6298.4698.450.61
2533365-53336598.90299.56
3526247-52624797.58298.23
4523946-52394697.15597.81
5525701-52570197.48198.14
6527618-52761897.83698.49
45min1526245-52624597.58197.170.4798.4097.980.47
2526366-52636697.60498.42
3523508-52350897.07497.89
4519678-51967896.36497.18
5523790-52379097.12697.95
6524472-52447297.25398.07
极限1522769-52276996.93797.020.3697.9298.000.36
2525828-52582897.50498.49
3522269-52226996.84497.82
4525194-52519497.38798.36
5521016-52101696.61297.60
6522280-52228096.84697.83
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