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%
19.952119521198210162139721061211730.71
210.142134921498214240.50
单位质量响应值RSD%判断
2127.942112.820.51数据可信
长期3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
20251104211250442514625095100.98100.770.32100.44%～101.10%
2250862512625106101.02
3250332517925106101.02
4249382488324910100.23
5252032479324998100.59
6251452495225048100.79
20251105211247502511924934100.33100.801.2399.50%～102.09%
2253142511925216101.47
3250462526625156101.22
4253642548425424102.30
5250042508925046100.78
624622244202452198.67
20251106211254032540625404102.22102.221.82100.27%～104.17%
2249252508025002100.60
3254342537825406102.23
4261642594226053104.83
524712248962480499.81
6256672583625752103.62
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%
113.548063581642820888146781039813740.69
213.658176782321820440.48
单位质量响应值RSD%判断
6009.906010.550.01数据可信
长期3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
2025110421190012897438987896.9496.961.2095.75%～98.18%
291199910719113598.30
390658907369069797.82
487988880708802994.95
589277899588961896.66
690417896299002397.10
2025110521188524883888845695.4197.481.8395.61%～99.35%
290911910729099298.14
389700901828994197.01
4926549316492909100.21
591441908729115698.32
688328893418883495.81
2025110621190998906269081297.9599.211.8897.27%～101.16%
290101903749023897.33
391738923299203499.27
4935889355193570100.92
590517909769074697.88
6945379446694502101.93
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%
19.952109921322212062138521268212560.52
210.142156721617215920.17
单位质量响应值RSD%判断
2136.282129.390.23数据可信
长期3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
2025110421124975247112484399.3899.650.8698.76%～100.54%
224855251122498499.94
324707247712473998.96
424876245272470298.82
5253482523125290101.17
624968248422490599.63
2025110521124744246012467298.70100.001.8798.04%～101.95%
224888248382486399.46
3257782542925604102.42
4255012544325472101.90
524891250652497899.92
624238245502439497.58
20251106211251672502225094100.38101.571.6599.82%～103.32%
2252142517525194100.78
3257952578825792103.18
4256672558325625102.51
524779248502481499.26
6257112594625828103.32
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%
113.548165382280815408205982165819390.40
213.658252581679821020.73
单位质量响应值RSD%判断
6051.626014.800.44数据可信
长期3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
2025110421190239898449004296.7596.361.1395.22%～97.50%
290460910689076497.52
389068896298934896.00
488119883898825494.83
590521909449073297.49
688964889188894195.57
2025110521189762893258954496.2197.131.4695.65%～98.62%
289562901998988096.57
391912918779189498.74
491441912159132898.13
591244913279128698.09
688970879498846095.05
2025110621191242908289103597.8298.941.5497.35%～100.53%
291445910409124298.04
391532920219177698.61
4941259354293834100.82
590821906429073297.49
6934709427193870100.86
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