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%
111.394709614707904707434706414703294706930.05
211.514729024732374730700.06
单位质量响应值RSD%判断
41325.1141100.780.39数据可信
长期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146957246938346947897.34104.293.62100.33%～108.24%
2503511503099503305104.35
3523414523539523476108.54
4511050510938510994105.95
5501350501181501266103.93
6509227509456509342105.61
2024040921批1485403485225485314100.62103.072.9299.92%～106.23%
2494352494394494373102.50
3520517520614520566107.93
4499764499740499752103.62
547969847944747957299.43
6503359503068503214104.34
2024041021批1502463502792502628104.21104.111.14102.87%～105.35%
2512158511999512078106.17
3497781497812497796103.21
4497360497485497422103.13
5504853504740504796104.66
6498038498231498134103.28
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%
111.184297184293444292714293154291924293680.05
211.154303604306214304900.05
单位质量响应值RSD%判断
38405.0138608.970.38数据可信
长期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1428942428866428904100.25100.070.9099.12%～101.01%
242735242686742711099.83
3430669430848430758100.68
4429256429076429166100.31
5432017431665431841100.93
642115442088642102098.40
2024040921批140625140616840621094.9495.133.4391.71%～98.55%
242155442172442163998.55
341269741279941274896.47
438710638701838706290.47
539448239432639440492.18
642024341976842000698.17
2024041021批1441942441944441943103.29100.874.0196.63%～105.12%
2436978436803436890102.11
3438271438187438229102.43
4437754438034437894102.35
5438135438059438097102.39
639649339639239644292.66
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