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 14.333750603746133748923749743746603748400.06
2 14.473742303741033741660.03
单位质量响应值RSD%判断
26157.7125858.050.82数据可信
供试品溶液-B117113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%
5min1252540-25254067.05568.174.1067.0568.174.10
2237335-23733563.01763.02
3265251-26525170.43070.43
4263855-26385570.05970.06
5262035-26203569.57669.58
6259379-25937968.87168.87
10min1339400-33940090.11889.251.4490.2389.361.43
2342893-34289391.04591.15
3333584-33358488.57488.69
4330614-33061487.78587.90
5338372-33837289.84589.96
6331977-33197788.14788.26
15min1351506-35150693.33292.521.2793.5992.781.26
2354776-35477694.20194.46
3346429-34642991.98492.25
4344053-34405391.35391.62
5350036-35003692.94293.21
6343807-34380791.28891.55
20min1355957-35595794.51493.661.4194.9394.081.41
2360205-36020595.64296.06
3349830-34983092.88793.31
4349235-34923592.72993.14
5354336-35433694.08494.50
6346919-34691992.11492.53
30min1360770-36077095.79294.941.3196.3795.511.31
2363523-36352396.52397.10
3356253-35625394.59395.17
4355763-35576394.46395.03
5358976-35897695.31695.89
6350091-35009192.95793.52
45min1363157-36315796.42696.001.5497.1696.731.53
2365816-36581697.13297.87
3366603-36660397.34198.07
4361175-36117595.90096.63
5361285-36128595.92996.67
6351191-35119193.24993.97
60min1363981-36398196.64596.081.5197.5496.981.51
2367434-36743497.56298.46
3364480-36448096.77797.67
4362502-36250296.25297.14
5361215-36121595.91096.81
6351591-35159193.35594.23
极限1362898-36289896.35796.061.5897.4197.111.57
2368483-36848397.84098.90
3364066-36406696.66797.72
4362893-36289396.35697.40
5361062-36106295.87096.93
6351290-35129093.27594.31
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 14.333751753753603757133757293756033755160.07
2 14.473784413780553782480.08
单位质量响应值RSD%判断
26204.8826140.150.18数据可信
供试品溶液-B111406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%
5min1320223-32022384.48981.562.9584.4981.562.96
2312760-31276082.51982.52
3302348-30234879.77279.77
4301551-30155179.56279.56
5318253-31825383.96983.97
6299509-29950979.02379.02
10min1350443-35044392.46289.572.7192.6089.702.71
2346053-34605391.30491.44
3333376-33337687.95988.09
4329303-32930386.88487.02
5346483-34648391.41791.56
6331132-33113287.36787.50
15min1358748-35874894.65391.672.5394.9591.952.53
2350768-35076892.54892.84
3342954-34295490.48690.77
4336585-33658588.80589.08
5355059-35505993.68093.97
6340451-34045189.82690.10
20min1364566-36456696.18892.882.5196.6493.322.51
2354462-35446293.52293.97
3348085-34808591.84092.27
4341683-34168390.15190.58
5358960-35896094.70995.16
6344524-34452490.90091.33
30min1365842-36584296.52594.411.9397.1495.001.94
2359713-35971394.90895.51
3353452-35345293.25693.84
4349941-34994192.32992.91
5365557-36555796.45097.06
6352458-35245892.99393.57
45min1368456-36845697.21495.881.3197.9996.631.32
2362547-36254795.65596.41
3360439-36043995.09995.84
4358314-35831494.53995.27
5370043-37004397.63398.40
6360657-36065795.15795.89
60min1369291-36929197.43595.891.3498.3796.801.35
2364673-36467396.21697.13
3361132-36113295.28296.18
4358078-35807894.47695.36
5368656-36865697.26798.20
6358828-35882894.67495.57
极限1368915-36891597.33695.901.2398.4396.971.24
2364378-36437896.13897.22
3361636-36163695.41596.47
4358418-35841894.56695.61
5368224-36822497.15398.25
6359268-35926894.79095.84
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