依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.394729244732704745974727084725164732030.18
211.514704934710004707460.08
单位质量响应值RSD%判断
41545.4840898.871.11数据可信
加速3月-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
2024040821批1512260511992512126106.17104.431.54102.75%～106.11%
2506463505196505830104.86
3512118511714511916106.12
4499226499495499360103.52
5500648500859500754103.81
6492066492757492412102.08
2024040921批1499615499614499614103.57103.201.41101.69%～104.72%
2506759506738506748105.05
3505063504783504923104.67
4490179489955490067101.59
5493565493294493430102.29
6492501492162492332102.06
2024041021批1494411494194494302102.47101.481.4599.94%～103.02%
2489819489810489814101.54
348211048195948203499.93
4492799492854492826102.16
5498112498158498135103.26
648009548025448017499.54
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号ZT-705-231101-1-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(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.184308834313074311954309664306134309930.07
211.154292564297074294820.08
单位质量响应值RSD%判断
38550.3638518.570.06数据可信
加速3月-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
2024040821批141102341114241108296.01100.012.2797.63%～102.39%
2434427433747434087101.38
3434345434357434351101.45
442671042700442685799.70
5437916437670437793102.25
642517642485242501499.27
2024040921批1437058436723436890102.04100.474.5795.66%～105.29%
2438710438423438566102.43
3441305441147441226103.05
439033439026239029891.16
5438840438616438728102.47
6435523435259435391101.69
2024041021批1438670438595438632102.4599.873.3696.36%～103.38%
2431391431224431308100.74
3429984430131430058100.44
4434916434841434878101.57
539890739918739904793.20
6431763431549431656100.82
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