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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.113823683820743822573820463824653822420.05
212.143824843823863824350.02
单位质量响应值RSD%判断
31564.1631502.060.14数据可信
供试品溶液-BXJVV61批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1322524-32252477.52676.304.2077.5376.314.20
2320114-32011476.94776.95
3339244-33924481.54581.55
4301622-30162272.50272.50
5306585-30658573.69573.70
6314537-31453775.60775.61
10min1357510-35751085.93685.181.6686.0785.311.67
2354016-35401685.09685.22
3363225-36322587.31087.45
4349129-34912983.92284.04
5355475-35547585.44785.57
6346913-34691383.38983.51
15min1363939-36393987.48286.541.4487.7586.811.44
2360639-36063986.68886.96
3367131-36713188.24988.53
4359081-35908186.31486.57
5352620-35262084.76185.03
6356691-35669185.73986.00
20min1365227-36522787.79187.401.1888.2187.811.18
2359269-35926986.35986.77
3370278-37027889.00589.43
4363334-36333487.33687.74
5364692-36469287.66388.07
6358733-35873386.23086.64
30min1372447-37244789.52790.343.6790.0990.903.66
2370190-37019088.98489.54
3403276-40327696.93797.51
4373341-37334189.74290.29
5371167-37116789.21989.77
6364648-36464887.65288.20
45min1376946-37694690.60890.121.0791.3290.831.08
2375832-37583290.34091.05
3381322-38132291.66092.40
4371536-37153689.30890.01
5373506-37350689.78190.48
6370452-37045289.04789.74
60min1386113-38611392.81291.211.0093.6892.071.00
2378160-37816090.90091.76
3380865-38086591.55092.44
4377817-37781790.81791.67
5378715-37871591.03391.88
6374930-37493090.12390.97
极限1395751-39575195.12894.061.5596.1595.071.55
2392079-39207994.24695.25
3398474-39847495.78396.83
4391221-39122194.03995.04
5389364-38936493.59394.60
6380976-38097691.57792.57
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2.0对照品来源自制对照品使用方法直接使用
对照品含量(%)90.50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%
112.113820693822373815743821963820623820280.07
212.143848353848133848240.01
单位质量响应值RSD%判断
31546.4931698.850.35数据可信
供试品溶液-BXJVV61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%
5min1392836-39283694.16190.234.4794.1690.244.47
2353946-35394684.83984.84
3371313-37131389.00289.00
4378791-37879190.79490.79
5364075-36407587.26787.27
6397781-39778195.34695.35
10min1402123-40212396.38796.083.3596.5496.233.35
2385874-38587492.49292.63
3396686-39668695.08395.23
4417797-417797100.144100.29
5387760-38776092.94493.09
6414809-41480999.42799.59
15min1402525-40252596.48396.602.0696.8096.912.06
2395538-39553894.80895.10
3403155-40315596.63496.94
4403034-40303496.60596.92
5395571-39557194.81695.12
6418217-418217100.244100.57
20min1401526-40152696.24496.931.8496.7297.401.84
2398424-39842495.50095.95
3403192-40319296.64397.11
4404093-40409396.85997.34
5400080-40008095.89796.36
6418960-418960100.422100.91
30min1401578-40157896.25697.101.7896.8997.731.79
2399125-39912595.66896.28
3404216-40421696.88897.52
4402203-40220396.40697.05
5404208-40420896.88697.50
6419299-419299100.504101.16
45min1400519-40051996.00297.251.8596.8098.051.85
2399616-39961695.78696.56
3404933-40493397.06097.85
4402209-40220996.40797.21
5407298-40729897.62798.41
6419866-419866100.640101.47
60min1400002-40000295.87897.071.8896.8498.031.88
2398875-39887595.60896.54
3402882-40288296.56997.52
4401211-40121196.16897.13
5407775-40777597.74198.68
6419167-419167100.472101.47
极限1400038-40003895.88797.131.9597.0198.251.94
2398286-39828695.46796.56
3402599-40259996.50197.61
4401275-40127596.18397.31
5410131-41013198.30699.41
6418958-418958100.422101.58
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