枸橼酸西地那非口崩项目信息
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%
113.914750934756864749474757634758614754700.09
213.914773634779574776600.09
单位质量响应值RSD%判断
34181.8834339.320.33数据可信
供试品溶液-2024041121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%
2min1405495-40549574.91270.695.7674.9170.695.75
2379293-37929370.07170.07
3407114-40711475.21175.21
4368540-36854068.08568.08
5385658-38565871.24771.25
6349759-34975964.61564.62
5min1531533-53153398.19697.071.9498.2097.071.94
2537406-53740699.28199.28
3533437-53343798.54898.55
4519346-51934695.94595.94
5511324-51132494.46394.46
6519610-51961095.99495.99
10min1539032-53903299.58299.671.2399.5899.681.23
2547526-547526101.151101.15
3539545-53954599.67699.68
4542987-542987100.312100.31
5527581-52758197.46697.47
6540531-54053199.85999.86
15min1539800-53980099.72499.951.1799.7299.951.17
2549300-549300101.479101.48
3540316-54031699.81999.82
4543747-543747100.453100.45
5530199-53019997.95097.95
6542921-542921100.300100.30
20min1540326-54032699.821100.111.2599.82100.101.25
2551354-551354101.858101.86
3540911-54091199.92999.93
4544721-544721100.633100.63
5530762-53076298.05498.05
6543149-543149100.342100.34
30min1540372-54037299.829100.151.1099.83100.161.10
2548494-548494101.330101.33
3542629-542629100.246100.25
4545127-545127100.708100.71
5531372-53137298.16798.17
6544809-544809100.649100.65
45min1539430-53943099.655100.221.2699.66100.221.26
2551375-551375101.862101.86
3542886-542886100.294100.29
4545928-545928100.856100.86
5531075-53107598.11298.11
6544118-544118100.521100.52
极限1540740-54074099.897100.361.1999.90100.361.19
2552021-552021101.981101.98
3542081-542081100.145100.14
4546268-546268100.918100.92
5532858-53285898.44198.44
6545384-545384100.755100.76
枸橼酸西地那非口崩项目信息
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%
113.914773634769584771384769224772474771260.04
213.914768124761154764640.11
单位质量响应值RSD%判断
34300.9334253.340.10数据可信
供试品溶液-2024041221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%
2min1336228-33622862.08566.448.9662.0966.448.96
2364716-36471667.34567.35
3322334-32233459.51959.52
4412616-41261676.19076.19
5375834-37583469.39869.40
6347140-34714064.10064.10
5min1517994-51799495.64897.561.1195.6597.561.11
2532770-53277098.37798.38
3525390-52539097.01497.01
4529520-52952097.77797.78
5533474-53347498.50798.51
6530910-53091098.03398.03
10min1534514-53451498.69999.350.5398.7099.350.53
2541232-54123299.93999.94
3537501-53750199.25099.25
4535379-53537998.85998.86
5541264-54126499.94599.95
6538284-53828499.39599.40
15min1537569-53756999.26399.980.6899.2699.980.68
2547059-547059101.015101.02
3539870-53987099.68899.69
4537986-53798699.34099.34
5543415-543415100.342100.34
6542660-542660100.203100.20
20min1538574-53857499.449100.020.5999.45100.020.58
2545089-545089100.652100.65
3540998-54099899.89699.90
4537929-53792999.32999.33
5545378-545378100.705100.70
6541980-541980100.077100.08
30min1539575-53957599.63399.930.5499.6399.930.55
2544148-544148100.478100.48
3540220-54022099.75299.75
4536930-53693099.14599.14
5544624-544624100.566100.57
6541661-541661100.019100.02
45min1539838-53983899.68299.940.5099.6899.940.50
2545872-545872100.796100.80
3541852-541852100.054100.05
4538863-53886399.50299.50
5541932-541932100.069100.07
6538940-53894099.51699.52
极限1538348-53834899.40799.880.5599.4199.880.55
2544357-544357100.516100.52
3540270-54027099.76299.76
4537153-53715399.18699.19
5544084-544084100.466100.47
6541332-54133299.95899.96
枸橼酸西地那非口崩项目信息
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%
113.914757714772834765234764644772874766660.14
213.914783554783504783520.01
单位质量响应值RSD%判断
34267.8634389.070.25数据可信
供试品溶液-2024041321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%
2min1326826-32682660.25970.909.1260.2670.909.12
2397120-39712073.21973.22
3420030-42003077.44377.44
4397244-39724473.24273.24
5407836-40783675.19575.20
6358166-35816666.03766.04
5min1503534-50353492.84097.882.6092.8497.882.60
2536014-53601498.82898.83
3539790-53979099.52499.52
4530769-53076997.86197.86
5539613-53961399.49299.49
6535608-53560898.75398.75
10min1529857-52985797.69399.501.1597.6999.501.15
2544033-544033100.307100.31
3544939-544939100.474100.47
4538576-53857699.30099.30
5545035-545035100.491100.49
6535440-53544098.72298.72
15min1532314-53231498.14699.581.2498.1599.581.24
2545157-545157100.514100.51
3545989-545989100.667100.67
4541184-54118499.78199.78
5544711-544711100.432100.43
6531182-53118297.93797.94
20min1534670-53467098.58099.861.0498.5899.861.04
2545302-545302100.541100.54
3546744-546744100.806100.81
4541144-54114499.77499.77
5546736-546736100.805100.80
6535146-53514698.66898.67
30min1530984-53098497.90199.631.5597.9099.621.55
2546007-546007100.671100.67
3546758-546758100.809100.81
4541528-54152899.84599.84
5547802-547802101.002101.00
6528970-52897097.52997.53
45min1531571-53157198.009100.001.3198.01100.001.31
2545926-545926100.656100.66
3548287-548287101.091101.09
4543436-543436100.197100.20
5549063-549063101.234101.23
6536044-53604498.83498.83
极限1534774-53477498.59999.661.1998.6099.661.18
2545922-545922100.655100.65
3547463-547463100.939100.94
4540232-54023299.60699.61
5543347-543347100.180100.18
6531285-53128597.95697.96
枸橼酸西地那非口崩项目信息
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%
113.914771864772794773894770174757634769270.14
213.914797914784684791300.20
单位质量响应值RSD%判断
34286.6334445.000.33数据可信
供试品溶液-2024041321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%
2min1350551-35055164.56369.788.6764.5669.788.67
2409613-40961375.44175.44
3408856-40885675.30175.30
4406729-40672974.91074.91
5357446-35744665.83365.83
6339996-33999662.61962.62
5min1522967-52296796.31896.263.0596.3296.263.05
2531121-53112197.82097.82
3537321-53732198.96298.96
4536934-53693498.89098.89
5498066-49806691.73291.73
6509627-50962793.86193.86
10min1536533-53653398.81798.791.0998.8298.791.09
2532905-53290598.14898.15
3542700-54270099.95299.95
4544125-544125100.215100.21
5530970-53097097.79297.79
6531066-53106697.81097.81
15min1536236-53623698.76299.031.0098.7699.041.00
2536330-53633098.77998.78
3544844-544844100.347100.35
4543656-543656100.128100.13
5533227-53322798.20898.21
6531974-53197497.97797.98
20min1536538-53653898.81798.921.2898.8298.921.28
2535849-53584998.69198.69
3544195-544195100.228100.23
4545610-545610100.488100.49
5532975-53297598.16198.16
6527504-52750497.15497.15
30min1537106-53710698.92298.980.9498.9298.980.95
2535906-53590698.70198.70
3543982-543982100.188100.19
4542887-54288799.98799.99
5533310-53331098.22398.22
6531487-53148797.88797.89
45min1537044-53704498.91198.901.0398.9198.901.03
2533494-53349498.25798.26
3542453-54245399.90799.91
4544776-544776100.335100.33
5533033-53303398.17298.17
6531251-53125197.84497.84
极限1536263-53626398.76799.000.8798.7799.000.87
2534900-53490098.51698.52
3541604-54160499.75099.75
4544933-544933100.364100.36
5534660-53466098.47298.47
6532956-53295698.15898.16
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