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%
111.394730504731754728924736494734624732460.07
211.514742814747794745300.08
单位质量响应值RSD%判断
41549.2541227.630.55数据可信
中间条件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1499245500373499809103.19102.404.7397.32%～107.47%
2517269517168517218106.79
3502251501502501876103.62
445016445020545018492.95
5507758507695507726104.83
6498985498744498864103.00
2024040921批1510398510383510390105.38102.052.2299.67%～104.43%
248307748241548274699.67
3500507500452500480103.33
4489174489026489100100.98
548360848330848345899.82
6499618499320499469103.12
2024041021批147790047819747804898.70100.522.0998.32%～102.72%
247174647176347175497.40
3489309489262489286101.02
4489060489300489180101.00
5494124493984494054102.00
6498750499205498978103.02
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%
111.184282374282864277604273494276794278620.10
211.154290934290594290760.01
单位质量响应值RSD%判断
38270.3038482.150.40数据可信
中间条件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142453842534842494399.6698.922.6596.18%～101.67%
241211941241141226596.69
342702142428042565099.82
4431845431110431478101.19
540444440416140430294.82
6432035432320432178101.36
2024040921批142003442027642015598.5496.894.4192.41%～101.36%
2431622431439431530101.20
340138740107740123294.10
439160539123139141891.80
5434862434739434800101.97
639959939952339956193.71
2024041021批142373442360542367099.3693.786.0287.85%～99.70%
238565238539138552290.41
336948236973036960686.68
440843440832840838195.77
538313538284938299289.82
6428951429073429012100.61
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