氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991430139141681114105701414241141062214164770.58
211.141430894142517614280350.29
单位质量响应值RSD%判断
128887.81128189.860.39数据可信
影响因素30天-供试品溶液-2024041821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%
240min1168506-16850611.62311.490.9611.6211.490.97
2165799-16579911.43711.44
3163872-16387211.30411.30
4167284-16728411.53911.54
5166813-16681311.50711.51
6167256-16725611.53711.54
480min1291305-29130520.09419.971.7020.1119.991.70
2289115-28911519.94319.96
3282049-28204919.45619.47
4287060-28706019.80119.82
5296867-29686720.47820.49
6290835-29083520.06220.08
720min1383071-38307126.42426.381.8226.4726.431.81
2380159-38015926.22326.27
3372146-37214625.67025.72
4380233-38023326.22826.28
5392791-39279127.09427.14
6386607-38660726.66826.72
1440min1558639-55863938.53538.752.6038.6238.842.60
2556533-55653338.38938.48
3550442-55044237.96938.05
4551038-55103838.01038.10
5564491-56449138.93839.03
6589565-58956540.66840.76
极限1588750-58875040.61241.362.9140.7641.502.91
2594082-59408240.97941.12
3581138-58113840.08740.23
4601650-60165041.50141.64
5600281-60028141.40741.55
6631665-63166543.57243.72
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.991411459140752014142381410221140923714105350.18
211.141421063142158614213240.03
单位质量响应值RSD%判断
128347.13127587.430.42数据可信
影响因素30天-供试品溶液-2024041821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%
240min1165204-16520411.44711.137.5911.4511.137.60
2172958-17295811.98411.98
3148292-14829210.27510.27
4170947-17094711.84411.84
5143210-1432109.9239.92
6163344-16334411.31811.32
480min1286234-28623419.83219.378.4019.8519.398.41
2299652-29965220.76220.78
3243604-24360416.87916.89
4292110-29211020.24020.26
5257448-25744817.83817.85
6298691-29869120.69620.71
720min1384825-38482526.66425.735.9526.7125.785.94
2391637-39163727.13627.18
3339956-33995623.55523.60
4374000-37400025.91425.96
5348456-34845624.14424.19
6389407-38940726.98127.03
1440min1580983-58098340.25538.084.7640.3438.174.76
2571664-57166439.60939.70
3520702-52070236.07836.15
4558987-55898738.73138.82
5517754-51775435.87435.95
6547839-54783937.95838.05
极限1615647-61564742.65740.764.8342.8040.904.83
2609100-60910042.20342.35
3562154-56215438.95039.08
4592099-59209941.02541.17
5545149-54514937.77237.90
6605235-60523541.93542.08
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