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%
110.661474223147454714821291473758147305714755430.26
210.611474862147506714749640.01
单位质量响应值RSD%判断
138418.67139016.400.31数据可信
长期24月-供试品溶液-2024041721批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min11008401009941009176.7206.786.876.726.786.84
28848388614885485.8965.90
31045991043911044956.9586.96
41060871054661057767.0437.04
51026741027261027006.8386.84
61083081085821084457.2217.22
120min139570839578039574426.35125.324.8726.3625.334.88
235352835364135358423.54423.55
338805638837238821425.85025.86
437942537876037909225.24225.25
536418836391736405224.24124.25
640104940120540112726.71026.72
240min193639093693393666262.36956.708.1862.4256.748.18
274013774075174044449.30449.35
383659283681283670255.71355.76
483088683107983098255.33255.38
584929184937684933456.55456.60
691498491436191467260.90560.96
480min1153083015298461530338101.900100.313.33102.04100.443.34
214054791405199140533993.57793.69
3152028415210181520651101.255101.39
4153783115392341538532102.446102.58
5152641915266181526518101.646101.78
6151832515168061517566101.050101.19
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%
110.661477199147397714751801473059147394014746710.11
210.611470151147140414707780.07
单位质量响应值RSD%判断
138336.87138621.870.15数据可信
长期24月-供试品溶液-2024041821批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min18731287543874285.8326.005.305.836.005.29
29621696588964026.4306.43
38516585811854885.7025.70
49195991905919326.1326.13
59393293843938886.2626.26
68476984919848445.6595.66
120min134683934683834683823.13423.918.7723.1423.918.76
237578037628137603025.08225.09
330728030733630730820.49820.51
439523739524939524326.36326.37
537826837804337815625.22325.23
634685234684534684823.13523.14
240min180751380824380787853.88654.068.0753.9354.108.07
284911884981784946856.66056.71
368201868145268173545.47245.51
485499185485985492557.02457.07
584367884309084338456.25456.30
682578082546082562055.07055.11
480min1150886315092191509041100.654100.390.68100.78100.520.68
214920201492234149212799.52699.66
3150533615052941505315100.406100.51
4152187715224101522144101.528101.66
5149984914994371499643100.028100.16
6150214715024211502284100.204100.33
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