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%
112.077555487559297559147548547538077552100.12
212.147585057588237586640.03
单位质量响应值RSD%判断
62569.1862492.920.09数据可信
供试品溶液-BXK1KP1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1741030-74103089.44790.027.8289.4590.027.82
2742964-74296489.68189.68
3797989-79798996.32396.32
4740234-74023489.35189.35
5644333-64433377.77577.78
6808272-80827297.56497.56
10min1787334-78733495.03695.204.2595.1995.354.26
2784696-78469694.71894.87
3812053-81205398.02098.18
4790261-79026195.39095.54
5729640-72964088.07288.20
6828080-82808099.955100.12
15min1801505-80150596.74797.403.4097.0597.713.41
2799510-79951096.50696.81
3837987-837987101.151101.47
4814259-81425998.28698.59
5760058-76005891.74492.02
6828251-82825199.975100.30
20min1810408-81040897.82298.402.7298.2998.882.72
2806351-80635197.33297.80
3841054-841054101.521102.01
4825635-82563599.660100.13
5778386-77838693.95694.39
6829587-829587100.137100.63
30min1814893-81489398.36399.182.2198.9999.822.23
2811419-81141997.94498.57
3844317-844317101.915102.58
4836109-836109100.924101.56
5794691-79469195.92496.51
6828570-828570100.014100.68
45min1820404-82040499.02899.851.8699.82100.651.87
2815056-81505698.38399.18
3846822-846822102.217103.05
4844342-844342101.918102.72
5809681-80968197.73498.48
6826860-82686099.808100.64
60min1821695-82169599.18499.981.74100.14100.941.75
2815586-81558698.44799.40
3844468-844468101.933102.93
4847585-847585102.309103.29
5814595-81459598.32799.24
6825772-82577299.676100.67
90min1824091-82409199.473100.341.68100.60101.471.67
2816386-81638698.54399.66
3842479-842479101.693102.86
4853542-853542103.028104.17
5827273-82727399.857100.93
6823651-82365199.420100.58
120min1-0.0000.00-1.291.302.81
2-0.0001.29
3-0.0001.34
4-0.0001.32
5-0.0001.24
6-0.0001.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.291.302.81
2-0.0001.29
3-0.0001.34
4-0.0001.32
5-0.0001.24
6-0.0001.33
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%
112.077576037585697573577572897565477574730.10
212.147581397580757581070.01
单位质量响应值RSD%判断
62756.6762447.030.35数据可信
供试品溶液-BXK1KP1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%
5min1723757-72375787.26489.963.5287.2689.963.52
2729545-72954587.96287.96
3739353-73935389.14489.14
4737902-73790288.96988.97
5749844-74984490.40990.41
6796433-79643396.02796.03
10min1780328-78032894.08595.852.6794.2396.002.67
2775572-77557293.51193.66
3792196-79219695.51695.66
4788875-78887595.11595.26
5797860-79786096.19996.35
6834886-834886100.663100.82
15min1791705-79170595.45796.582.0395.7696.892.03
2787283-78728394.92395.23
3798454-79845496.27096.58
4793284-79328495.64795.95
5803322-80332296.85797.17
6832100-832100100.327100.65
20min1800913-80091396.56797.122.2197.0397.592.22
2788579-78857995.08095.54
3803146-80314696.83697.30
4797034-79703496.09996.57
5803075-80307596.82797.30
6840048-840048101.285101.78
30min1801702-80170296.66297.852.0797.2898.482.07
2802713-80271396.78497.40
3803945-80394596.93297.56
4810024-81002497.66598.29
5805806-80580697.15797.79
6845169-845169101.903102.57
45min1814047-81404798.15098.421.5998.9399.211.60
2810643-81064397.74098.52
3809436-80943697.59498.39
4808319-80831997.46098.25
5812728-81272897.99198.79
6842360-842360101.564102.40
60min1817388-81738898.55398.401.4599.5099.361.45
2808401-80840197.47098.41
3808011-80801197.42398.38
4807224-80722497.32898.28
5817246-81724698.53699.50
6838183-838183101.060102.06
90min1820882-82088298.97498.831.32100.0999.951.32
2819339-81933998.78899.89
3812981-81298198.02299.14
4805669-80566997.14098.25
5821114-82111499.002100.13
6837936-837936101.031102.20
120min1-0.0000.00-1.281.291.97
2-0.0001.27
3-0.0001.28
4-0.0001.28
5-0.0001.29
6-0.0001.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.281.291.97
2-0.0001.27
3-0.0001.28
4-0.0001.28
5-0.0001.29
6-0.0001.34
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%
112.077575457571437573567571147572997572910.03
212.147576017571827573920.04
单位质量响应值RSD%判断
62741.5962388.140.40数据可信
供试品溶液-BXK1KP1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%
5min1181140-18114021.85322.583.0421.8522.583.04
2188936-18893622.79422.79
3195715-19571523.61223.61
4180557-18055721.78321.78
5187372-18737222.60522.60
6189385-18938522.84822.85
10min1287630-28763034.70034.542.1534.7434.582.15
2289030-28903034.86934.91
3292386-29238635.27435.31
4275836-27583633.27733.31
5282394-28239434.06934.11
6290461-29046135.04235.08
15min1357151-35715143.08842.452.2143.1842.542.21
2354672-35467242.78842.88
3357268-35726843.10243.20
4337253-33725340.68740.78
5349006-34900642.10542.20
6355649-35564942.90643.00
20min1402987-40298748.61748.071.9648.7848.241.96
2403766-40376648.71148.88
3403221-40322148.64648.82
4383281-38328146.24046.40
5399001-39900148.13648.30
6398400-39840048.06448.23
30min1465337-46533756.13955.541.8556.3955.791.85
2465048-46504856.10456.35
3463122-46312255.87256.12
4443523-44352353.50853.74
5460280-46028055.52955.77
6465008-46500856.10056.35
45min1524539-52453963.28262.791.7563.6263.131.75
2527944-52794463.69264.03
3523168-52316863.11663.46
4502467-50246760.61960.94
5522240-52224063.00463.34
6522600-52260063.04863.39
60min1563865-56386568.02667.811.4468.4768.261.44
2568140-56814068.54268.99
3563680-56368068.00468.45
4545903-54590365.85966.29
5565286-56528668.19768.64
6565634-56563468.23968.69
90min1610180-61018073.61474.171.5274.1774.731.52
2624884-62488475.38775.95
3616446-61644674.36974.93
4598570-59857072.21372.75
5620858-62085874.90275.46
6618006-61800674.55875.12
120min1645593-64559377.88678.231.0978.5778.911.10
2654432-65443278.95279.64
3648174-64817478.19778.88
4635948-63594876.72277.38
5653753-65375378.87079.55
6652996-65299678.77979.46
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1700886-70088684.55784.580.6285.3785.390.62
2701321-70132184.60985.43
3704969-70496985.04985.87
4692887-69288783.59184.38
5703843-70384384.91385.73
6702445-70244584.74585.56
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