艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273698313695423694603693423690323694410.08
214.323685443688103686770.06
单位质量响应值RSD%判断
25889.3525745.600.40数据可信
供试品溶液-B117113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%
5min1281801-28180175.37472.1610.4075.3772.1610.40
2278165-27816574.40274.40
3269082-26908271.97271.97
4293538-29353878.51378.51
5281262-28126275.23075.23
6214815-21481557.45757.46
10min1335703-33570389.79190.651.6889.9290.771.68
2345028-34502892.28692.41
3333523-33352389.20889.33
4341890-34189091.44691.58
5332496-33249688.93489.06
6344825-34482592.23192.33
15min1344475-34447592.13893.301.9492.4193.571.93
2353604-35360494.57994.86
3343754-34375491.94592.21
4350705-35070593.80494.09
5341438-34143891.32591.60
6358993-35899396.02196.27
20min1346915-34691592.79093.871.8793.2294.301.86
2355123-35512394.98695.42
3346829-34682992.76793.19
4353434-35343494.53494.97
5342837-34283791.70092.13
6360555-36055596.43996.85
30min1352494-35249494.28394.961.6994.8795.541.68
2358884-35888495.99296.59
3351584-35158494.03994.62
4357094-35709495.51396.11
5346621-34662192.71293.29
6363419-36341997.20597.77
45min1355878-35587895.18895.441.4795.9396.181.47
2360944-36094496.54397.30
3354260-35426094.75595.49
4358757-35875795.95896.71
5348258-34825893.15093.88
6362800-36280097.03997.77
60min1358577-35857795.91095.951.7996.8196.851.78
2368134-36813498.46699.38
3354857-35485794.91595.81
4359126-35912696.05696.97
5349303-34930393.42994.32
6362412-36241296.93597.83
极限1358126-35812695.78995.591.2896.8596.651.28
2361221-36122196.61797.70
3356163-35616395.26496.31
4358894-35889495.99497.07
5348863-34886393.31194.36
6360963-36096396.54897.60
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.273681143682053682453682393683283682260.03
214.323687213688573687890.03
单位质量响应值RSD%判断
25804.2025753.420.14数据可信
供试品溶液-B117113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%
5min1266947-26694771.50870.996.4471.5170.996.44
2270270-27027072.39872.40
3235945-23594563.20363.20
4284673-28467376.25676.26
5256444-25644468.69468.69
6275830-27583073.88773.89
10min1330539-33053988.54289.712.4288.6689.822.42
2331810-33181088.88389.00
3347239-34723993.01693.12
4337124-33712490.30690.43
5323701-32370186.71086.82
6338909-33890990.78490.91
15min1338509-33850990.67792.452.5390.9492.722.52
2340416-34041691.18891.46
3360296-36029696.51396.77
4345220-34522092.47592.75
5337047-33704790.28590.54
6349236-34923693.55193.83
20min1342402-34240291.72093.302.6092.1493.722.60
2343189-34318991.93192.35
3364149-36414997.54597.97
4348177-34817793.26793.70
5339355-33935590.90491.31
6352446-35244694.41094.84
30min1345993-34599392.68294.162.3293.2594.742.32
2346544-34654492.82993.40
3365853-36585398.00298.59
4351481-35148194.15294.74
5343925-34392592.12892.69
6355210-35521095.15195.74
45min1348031-34803193.22894.832.3893.9595.562.37
2348959-34895993.47694.21
3367505-36750598.44499.19
4353998-35399894.82695.57
5345482-34548292.54593.26
6360015-36001596.43897.18
60min1350568-35056893.90795.132.1394.7996.022.13
2349421-34942193.60094.48
3366851-36685198.26999.18
4354718-35471895.01995.92
5347802-34780293.16694.04
6361497-36149796.83597.74
极限1352352-35235294.38595.351.9595.4296.401.94
2348176-34817693.26794.31
3365675-36567597.95499.03
4353264-35326494.63095.69
5352959-35295994.54895.57
6363381-36338197.34098.41
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