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%
111.141460839146087114604101459730146037214604440.04
210.891412799141145314121260.07
单位质量响应值RSD%判断
131099.10129671.810.78数据可信
加速1月-供试品溶液-2024041521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%
30min11007781007081007436.8516.812.976.856.812.96
2100303999971001506.8116.81
31001881006591004246.8296.83
49475494286945206.4286.43
51022481021971022226.9526.95
61026451031921029186.9997.00
120min137006436946536976425.14525.654.2525.1625.664.26
235949136016135982624.47024.48
336930036930436930225.11425.12
437198337194337196325.29525.30
538865838858738862226.42826.44
640368440375740372027.45527.47
240min180983481024981004255.08656.034.4355.1356.084.43
278972278934078953153.69153.74
378614478627178620853.46553.51
482288182318282303255.96956.02
586125286135286130258.57258.62
687363887341087352459.40359.45
480min1151740315165031516953103.159102.520.45103.29102.650.45
2151125315116611511457102.785102.91
3150914915090821509116102.626102.75
4149961415006111500112102.014102.15
5149939514993121499354101.962102.10
6150809615083981508247102.567102.71
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%
111.141456612145555614554661455259145508714555960.05
210.891402032140180314019180.02
单位质量响应值RSD%判断
130663.91128734.441.06数据可信
加速1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%
30min11133411132581133007.7467.047.257.757.047.27
21026841028241027547.0257.02
31032621032211032427.0587.06
41031821032961032397.0587.06
58998690219901026.1606.16
61056041052851054447.2097.21
120min142129742147942138828.80827.134.4728.8227.144.47
239786639817439802027.21127.22
337550837510937530825.65825.67
441236541224941230728.18828.20
539224339252539238426.82626.83
638143138118838131026.06826.08
240min188764488716588740460.66858.452.2060.7258.502.20
284996884979484988158.10358.15
382976882985882981356.73156.78
485663285604485633858.54458.60
585723785677985700858.59058.64
684871384912784892058.03758.09
480min1152844615280811528264104.481102.561.49104.63102.701.49
2147906914784081478738101.095101.23
3152064115216501521146103.994104.13
4147792914785681478248101.061101.20
5150958815092591509424103.193103.33
6148530214851361485219101.538101.67
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%
111.141439399143865114388531438454143912614388970.03
210.891405756140585614058060.01
单位质量响应值RSD%判断
129164.90129091.460.05数据可信
加速1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%
30min11032991034381033687.0986.852.517.106.852.52
29752397615975696.6996.70
31006821005501006166.9096.91
49723197385973086.6826.68
59833897784980616.7336.73
61016141017221016686.9816.98
120min139556739551139553927.15926.427.0127.1726.437.01
236490236506636498425.06125.07
337546637519337533025.77225.78
437277937253137265525.58825.60
536517736543636530625.08325.09
643494043490243492129.86329.87
240min186424786377486401059.32656.824.8559.3856.884.85
279272179236179254154.41954.47
384990284939184964658.34058.39
483146483139483142957.08957.14
576608176568476588252.58952.64
686134386262586198459.18759.24
480min1151414815151251514636104.001102.880.88104.14103.010.88
2148304914822621482656101.805101.93
3150257815026221502600103.175103.31
4151141215111811511296103.772103.91
5148857014894901489030102.243102.37
6148976414893061489535102.277102.42
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