培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.074138041360414124144741355413910.10
210.124148041363414220.20
单位质量响应值RSD%判断
4110.334093.080.30数据可信
长期12月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2022081001批147317472774729798.38100.031.8498.10%～101.96%
2491414911749129102.19
347840477454779299.41
4492584916949214102.37
547828480234792699.69
647258471154718698.15
2022081101批148081480594807099.9999.361.1398.18%～100.53%
247856478634786099.55
3486624857248617101.13
447255472544725498.29
547603475844759499.00
647174472284720198.18
2022081201批1481634810848136100.1399.741.3098.39%～101.10%
2486284854948588101.07
3487694865448712101.33
447255473374729698.38
547653476294764199.10
647339473324733698.46
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091636921639611639601639401640821639270.09
214.161636571636821636700.02
单位质量响应值RSD%判断
11634.2811558.620.47数据可信
长期12月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2022081001批117626217638617632498.5799.261.6097.59%～100.92%
2180465180024180244100.76
317570417627517599098.38
4180736180391180564100.94
5179078178689178884100.00
617333317327217330296.88
2022081101批117504517473017488897.7697.901.4896.38%～99.42%
217693217667517680498.84
3179260179364179312100.24
417313317279217296296.69
517471117433617452497.56
617232617228817230796.32
2022081201批117824217785217804799.5398.892.0896.74%～101.04%
217815217780117797699.49
3183201182872183036102.32
417328817258017293496.67
517533417591117562298.18
617391717366517379197.15
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