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%
1 14.333755793753533754363755353754383754680.03
2 14.473752673751973752320.02
单位质量响应值RSD%判断
26201.5425931.720.74数据可信
供试品溶液-Z005796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%
5min1270440-27044071.64566.1910.4271.6566.1910.42
2248782-24878265.90865.91
3256944-25694468.07068.07
4280855-28085574.40474.40
5209126-20912655.40255.40
6232898-23289861.70061.70
10min1340274-34027490.14689.181.5390.2789.291.53
2333944-33394488.46988.58
3331291-33129187.76687.88
4339860-33986090.03690.16
5343191-34319190.91991.01
6331159-33115987.73187.83
15min1348267-34826792.26391.511.5592.5391.761.55
2340417-34041790.18490.44
3340874-34087490.30590.56
4350085-35008592.74593.02
5352130-35213093.28793.53
6340683-34068390.25490.50
20min1354406-35440693.89092.661.4394.3193.071.43
2345063-34506391.41591.82
3343954-34395491.12191.53
4353085-35308593.54093.97
5355051-35505194.06194.46
6346935-34693591.91092.31
30min1360258-36025895.44094.561.2996.0295.121.29
2350434-35043492.83793.40
3352473-35247393.37893.94
4359113-35911395.13795.72
5362155-36215595.94396.50
6357128-35712894.61195.16
45min1365748-36574896.89495.781.1497.6396.501.13
2355355-35535594.14194.86
3360184-36018495.42096.14
4360036-36003695.38196.12
5366435-36643597.07697.79
6361402-36140295.74396.45
60min1363641-36364196.33695.751.0497.2496.641.03
2355980-35598094.30795.18
3361599-36159995.79596.67
4358338-35833894.93195.83
5366341-36634197.05197.93
6362718-36271896.09296.96
极限1362702-36270296.08795.500.5297.1596.550.52
2359419-35941995.21896.25
3357360-35736094.67295.71
4360870-36087095.60296.66
5361389-36138995.74096.78
6361246-36124695.70296.73
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