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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
111.361540533154221415399531537644154394115408570.16
211.301538652153402415363380.22
单位质量响应值RSD%判断
135638.82135959.120.17数据可信
长期24月-供试品溶液-X0734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%
240min1224390-22439015.26214.695.4215.2614.695.43
2201455-20145513.70213.70
3232833-23283315.83715.84
4207073-20707314.08514.08
5219202-21920214.91014.91
6210639-21063914.32714.33
480min1397185-39718527.01626.203.5327.0426.223.52
2379013-37901325.78025.80
3395627-39562726.91026.93
4368375-36837525.05625.08
5398468-39846827.10327.13
6372194-37219425.31625.34
720min1536034-53603436.46035.603.2836.5235.663.28
2516118-51611835.10535.16
3536866-53686636.51636.58
4497442-49744233.83533.89
5540644-54064436.77336.84
6513385-51338534.91934.98
1440min1945471-94547164.30962.535.1264.4362.645.11
2838254-83825457.01657.13
3963221-96322165.51665.63
4919319-91931962.53062.64
5954870-95487064.94865.07
6894698-89469860.85560.97
极限1992546-99254667.51065.704.9867.7365.914.98
2876395-87639559.61059.81
3995210-99521067.69267.91
4959906-95990665.29065.49
51009861-100986168.68868.90
6961776-96177665.41865.62
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100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3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%
111.361539089153812515398371542247154402815406650.16
211.301518458151326315158600.25
单位质量响应值RSD%判断
135621.92134146.900.78数据可信
长期24月-供试品溶液-X0734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%
240min1218198-21819814.94214.739.1214.9414.739.11
2179840-17984012.31612.32
3211566-21156614.48814.49
4235018-23501816.09416.09
5231307-23130715.84015.84
6214945-21494514.72014.72
480min1411349-41134928.16926.686.1728.1926.706.17
2347129-34712923.77223.79
3396517-39651727.15427.18
4401133-40113327.47027.49
5405333-40533327.75727.78
6376228-37622825.76425.79
720min1581058-58105839.79136.895.4339.8636.955.43
2501336-50133634.33234.39
3537272-53727236.79336.86
4535144-53514436.64736.71
5561682-56168238.46438.53
6515543-51554335.30535.37
1440min1997433-99743368.30565.276.1468.4365.396.12
2982011-98201167.24967.35
3998867-99886768.40368.52
4977265-97726566.92467.04
5908201-90820162.19462.32
6855193-85519358.56458.68
极限11031060-103106070.60867.965.6770.8368.185.66
21047635-104763571.74371.95
31009063-100906369.10169.32
41014408-101440869.46769.69
5955676-95567665.44565.66
6896821-89682161.41561.62
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