盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.113880083878243879283876833875483877980.05
2 12.053869373869773869570.01
单位质量响应值RSD%判断
32022.9632112.610.20数据可信
供试品溶液-6021201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%
5min1397776-39777693.62693.483.4793.6393.483.47
2407609-40760995.94195.94
3414516-41451697.56697.57
4379058-37905889.22089.22
5400756-40075694.32894.33
6383168-38316890.18890.19
10min1407328-40732895.87496.221.7896.0396.381.78
2419948-41994898.84599.00
3411030-41103096.74696.91
4399786-39978694.09994.25
5412111-41211197.00097.16
6402549-40254994.75094.90
15min1406408-40640895.65896.032.3395.9796.352.33
2417358-41735898.23598.56
3412493-41249397.09097.41
4400069-40006994.16694.47
5417459-41745998.25998.58
6394257-39425792.79893.11
20min1374509-37450988.15095.504.2088.6295.974.18
2420412-42041298.95499.44
3417930-41793098.37098.86
4401162-40116294.42394.89
5415033-41503397.68898.17
6405317-40531795.40195.86
30min1409125-40912596.29796.062.0996.9296.692.09
2410973-41097396.73297.39
3418236-41823698.44299.09
4394649-39464992.89093.51
5413672-41367297.36898.01
6401981-40198194.61695.24
45min1404072-40407295.10895.091.2795.8995.881.27
2411982-41198296.97097.78
3406143-40614395.59696.41
4397635-39763593.59394.37
5399437-39943794.01794.82
6404722-40472295.26196.04
60min1395785-39578593.15895.092.1394.1096.052.13
2411763-41176396.91897.89
3406753-40675395.73996.71
4395541-39554193.10094.03
5415574-41557497.81598.78
6398677-39867793.83894.78
极限1394876-39487692.94495.662.3894.0496.782.37
2415931-41593197.89999.04
3415213-41521397.73098.86
4396568-39656893.34294.43
5413625-41362597.35798.48
6402408-40240894.71695.81
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.113875383881083878573875323879923878050.07
2 12.053868183869053868620.02
单位质量响应值RSD%判断
32023.5332104.730.18数据可信
供试品溶液-6021201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%
5min1405079-40507995.35696.901.2995.3696.901.29
2416819-41681998.12098.12
3417373-41737398.25098.25
4414593-41459397.59697.60
5409056-40905696.29296.29
6406942-40694295.79495.79
10min1405505-40550595.45697.302.4595.6297.462.45
2428598-428598100.892101.06
3418545-41854598.52698.69
4414842-41484297.65497.82
5412840-41284097.18397.34
6399675-39967594.08494.24
15min1387443-38744391.20496.373.3491.5296.703.33
2422296-42229699.40999.74
3422978-42297899.56999.90
4415125-41512597.72198.05
5406516-40651695.69496.02
6401953-40195394.62094.94
20min1404556-40455695.23397.222.1895.7097.702.18
2417006-41700698.16498.66
3415665-41566597.84898.34
4424903-424903100.023100.51
5415584-41558497.82998.31
6400339-40033994.24094.71
30min1408400-40840096.13898.081.6596.7798.731.66
2423636-42363699.724100.39
3422376-42237699.428100.08
4422403-42240399.434100.09
5410660-41066096.67097.31
6412480-41248097.09897.73
45min1413462-41346297.32997.711.4398.1298.521.43
2425503-425503100.164100.99
3410698-41069896.67997.50
4418217-41821798.44999.27
5413205-41320597.26998.07
6409439-40943996.38297.18
60min1391504-39150492.16097.142.7893.1198.122.76
2426088-426088100.301101.30
3413774-41377497.40398.39
4415944-41594497.91498.90
5416381-41638198.01698.98
6412306-41230697.05798.01
极限1397220-39722093.50697.562.4594.6198.692.44
2427031-427031100.523101.68
3419203-41920398.68199.83
4419083-41908398.65299.80
5412754-41275497.16398.29
6411377-41137796.83897.95
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.113884393877413880673883793883023881860.08
2 12.053851933855503853720.07
单位质量响应值RSD%判断
32055.0031981.080.17数据可信
供试品溶液-6021301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%
5min1390769-39076992.12091.485.2092.1291.485.20
2353384-35338483.30783.31
3405951-40595195.69995.70
4390339-39033992.01892.02
5379363-37936389.43189.43
6408604-40860496.32496.32
10min1393505-39350592.76593.722.9492.9293.872.94
2383021-38302190.29390.43
3404142-40414295.27295.43
4409539-40953996.54596.70
5386023-38602391.00191.15
6409068-40906896.43496.59
15min1393625-39362592.79394.863.8193.1095.163.81
2380214-38021489.63289.92
3416498-41649898.18598.50
4406665-40666595.86796.18
5396293-39629393.42293.72
6420999-42099999.24699.57
20min1393366-39336692.73294.443.3893.1994.903.38
2385178-38517890.80291.24
3410849-41084996.85397.34
4402545-40254594.89695.37
5390649-39064992.09192.55
6420966-42096699.23899.73
30min1391695-39169592.33893.792.9092.9694.422.90
2385160-38516090.79791.39
3401906-40190694.74595.39
4406887-40688795.91996.55
5387489-38748991.34791.96
6413974-41397497.59098.24
45min1392430-39243092.51194.733.3693.2895.513.36
2387289-38728991.29992.04
3412281-41228197.19197.99
4407301-40730196.01796.81
5391091-39109192.19692.96
6420620-42062099.15799.97
60min1387312-38731291.30593.762.5192.2394.702.52
2389853-38985391.90492.80
3409137-40913796.45097.41
4399398-39939894.15495.11
5390855-39085592.14093.06
6409808-40980896.60897.59
极限1391499-39149992.29294.073.2393.3795.163.23
2384657-38465790.67991.73
3407356-40735696.03097.15
4402012-40201294.77095.88
5389630-38963091.85192.92
6419011-41901198.77899.92
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 12.113869573868323867913870203866583868520.04
2 12.053869753873303871520.07
单位质量响应值RSD%判断
31944.8432128.800.41数据可信
供试品溶液-6021301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%
5min1388086-38808691.43493.272.9191.4393.272.91
2418201-41820198.52998.53
3386223-38622390.99591.00
4394747-39474793.00493.00
5393603-39360392.73492.73
6394334-39433492.90692.91
10min1390565-39056592.01895.382.7992.1795.532.79
2422989-42298999.65899.82
3411194-41119496.87997.03
4400149-40014994.27694.43
5398633-39863393.91994.07
6405465-40546595.52995.68
15min1394325-39432592.90495.432.9793.2195.752.96
2425904-425904100.344100.67
3410725-41072596.76897.08
4398510-39851093.89094.20
5395352-39535293.14693.46
6405585-40558595.55795.87
20min1399984-39998494.23795.722.6894.7096.192.67
2426002-426002100.367100.86
3412199-41219997.11597.59
4399900-39990094.21894.69
5399900-39990094.21894.68
6399621-39962194.15294.63
30min1393686-39368692.75495.903.4093.3796.533.39
2431147-431147101.580102.24
3414603-41460397.68298.32
4401989-40198994.71095.34
5397024-39702493.54094.16
6403776-40377695.13195.76
45min1397385-39738593.62594.882.7594.4095.672.74
2421389-42138999.281100.11
3410360-41036096.68297.48
4392155-39215592.39393.18
5395623-39562393.21093.99
6399285-39928594.07394.86
60min1395389-39538993.15595.093.4994.0896.043.48
2431001-431001101.545102.54
3405323-40532395.49596.46
4393219-39321992.64493.58
5397308-39730893.60794.54
6399290-39929094.07495.02
极限1396315-39631593.37394.833.5894.4695.943.56
2423207-42320799.709100.88
3415225-41522597.82898.95
4401317-40131794.55295.64
5395052-39505293.07594.17
6383863-38386390.43991.54
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