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%
114.203690313689503690133691073692983690800.04
214.313693483691243692360.05
单位质量响应值RSD%判断
25991.5525802.660.52数据可信
供试品溶液-B117113批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1159365-15936542.49540.8640.8342.4940.8640.83
2203214-20321454.18754.19
3145611-14561138.82738.83
4238134-23813463.49963.50
5107242-10724228.59628.60
665776-6577617.53917.54
10min1317956-31795684.78483.213.6084.8583.283.62
2320034-32003485.33885.43
3298452-29845279.58379.65
4325835-32583586.88486.99
5310321-31032182.74882.80
6299691-29969179.91379.94
15min1348032-34803292.80391.461.1393.0291.661.14
2342314-34231491.27991.51
3336159-33615989.63789.83
4344074-34407491.74892.00
5344057-34405791.74391.93
6343261-34326191.53191.69
20min1351591-35159193.75293.990.8194.1294.350.78
2353480-35348094.25694.64
3350258-35025893.39793.74
4348592-34859292.95393.36
5355656-35565694.83695.17
6355296-35529694.74095.06
30min1356426-35642695.04295.320.9895.5695.830.94
2356573-35657395.08195.62
3356178-35617894.97695.48
4352597-35259794.02194.58
5362000-36200096.52897.02
6361000-36100096.26196.73
45min1357657-35765795.37095.591.0696.0596.271.03
2357950-35795095.44896.15
3357087-35708795.21895.88
4352833-35283394.08494.80
5363246-36324696.86097.52
6362220-36222096.58797.22
60min1358327-35832795.54995.671.1096.3996.511.06
2357945-35794595.44796.31
3357631-35763195.36396.18
4352717-35271794.05394.92
5362404-36240496.63697.45
6363772-36377297.00097.79
极限1358161-35816195.50495.461.0096.5096.460.97
2357246-35724695.26096.28
3356151-35615194.96895.95
4352669-35266994.04095.07
5362617-36261796.69297.67
6361197-36119796.31497.27
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%
114.203703313702083701703702963703733702760.03
214.313713183710183711680.06
单位质量响应值RSD%判断
26075.7725937.670.38数据可信
供试品溶液-B117113批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1195466-19546651.90151.7724.9951.9051.7725.00
2245007-24500765.05665.06
3124774-12477433.13133.13
4148155-14815539.33939.34
5223861-22386159.44159.44
6232519-23251961.74061.74
10min1323928-32392886.01185.612.6786.1085.702.69
2326924-32692486.80786.92
3306655-30665581.42581.48
4320215-32021585.02585.09
5325052-32505286.31086.41
6331660-33166088.06488.17
15min1345029-34502991.61491.701.2891.8491.921.28
2343489-34348991.20591.46
3339738-33973890.20990.40
4351991-35199193.46393.67
5342980-34298091.07091.31
6348815-34881592.62092.87
20min1350654-35065493.10893.371.3593.4993.751.34
2348317-34831792.48792.89
3349655-34965592.84393.18
4360265-36026595.66096.02
5347458-34745892.25992.65
6353556-35355693.87894.28
30min1355363-35536394.35894.421.2994.9094.961.27
2352209-35220993.52194.08
3354769-35476994.20094.70
4364053-36405396.66697.19
5351066-35106693.21793.77
6356099-35609994.55495.11
45min1357514-35751494.92994.731.0995.6295.431.07
2354313-35431394.07994.79
3355405-35540594.36995.02
4364074-36407496.67197.35
5353191-35319193.78194.49
6356162-35616294.57095.29
60min1360930-36093095.83694.931.0696.6995.791.05
2354632-35463294.16495.04
3355435-35543594.37795.19
4363415-36341596.49697.34
5354048-35404894.00994.87
6356739-35673994.72495.60
极限1359154-35915495.36594.710.9396.3895.720.92
2354570-35457094.14895.18
3354369-35436994.09495.06
4362292-36229296.19897.20
5354411-35441194.10595.12
6355437-35543794.37895.41
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