瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.174796994779814807934801514802394797730.23
211.184752244755554753900.05
单位质量响应值RSD%判断
42951.9242521.470.72数据可信
影响因素5天-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024041021批1518342517024517683103.51100.902.4398.33%～103.46%
2516686516809516748103.32
348697748760148728997.43
449846149719349782799.54
5512426508503510464102.07
649722549811349766999.51
2024041021批149723649681249702499.38100.662.5597.97%～103.35%
2510702506899508800101.73
3516893514176515534103.08
448113647953848033796.04
5509173508123508648101.70
6509177511363510270102.03
l批1506204501869504036100.78100.001.2798.68%～101.33%
2499600500929500264100.03
349901350041049971299.92
449055948677748866897.71
5500604500848500726100.12
6507117507616507366101.45
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.284439754439124458394460284467904453090.30
211.244425374409064417220.27
单位质量响应值RSD%判断
39477.7539299.110.33数据可信
影响因素5天-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024041021批140155240015040085191.3694.833.1191.74%～97.92%
242650942659942655497.22
342209041887342048295.84
439824339880739852590.83
542864842392542628697.16
642331142412042371696.57
2024041021批141705741329741517794.6396.031.6094.42%～97.64%
242200442275742238096.27
341749941501541625794.87
442649242654442651897.21
543118243221943170098.39
641618341585741602094.82
l批142240342316842278696.3695.573.1092.47%～98.67%
242587742600342594097.08
343306143440443373298.86
439847439624239735890.57
541098541146641122693.73
642482342488042485296.83
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.174795354798724802964809144803154801860.11
211.184755954769314762630.20
单位质量响应值RSD%判断
42988.9042599.550.65数据可信
影响因素5天-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024041021批1504591504331504461100.73100.490.7999.67%～101.32%
2508840508928508884101.61
3502065502140502102100.26
4504747503591504169100.67
5503428503167503298100.50
649702749642449672699.19
2024041021批148524248405048464696.7796.861.5395.31%～98.42%
248976749076349026597.90
348230248614648422496.69
449422549162349292498.43
547427246897647162494.17
648752748632148692497.23
l批148325348398748362096.5794.863.2191.68%～98.05%
248562248504548533496.91
348864048915548889897.62
447797147718247757695.36
546720746630046675493.20
644840944829644835289.53
瑞舒伐他汀钙依折麦布片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.284440964454984464054457004452604453920.19
211.244414744425324420030.17
单位质量响应值RSD%判断
39485.1139324.110.29数据可信
影响因素5天-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024041021批140630240422840526592.3395.421.9593.47%～97.37%
243005143102543053898.09
341680341685541682994.97
442035041899141967095.61
541963441860941912295.49
642095342204242149896.03
2024041021批141638641541241589994.7595.921.1994.72%～97.11%
242258142313042285696.34
342517942467842492896.81
441685841515041600494.78
542034641650841842795.33
642840642746442793597.50
l批142414042509742461896.7496.071.1394.94%～97.21%
241415941350241383094.28
342458942488442473696.77
442617642572142594897.04
542435442146942291296.35
641782141836141809195.25
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