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2000
标示量(mg)10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%
110.053983639766397473979639855398000.12
210.153971240044398780.59
单位质量响应值RSD%判断
3960.203928.870.57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
2022081302批1472734708447178102.05102.600.99101.54%～103.67%
2483054791848112104.07
3469054689946902101.45
4476714790947790103.37
5475314760247566102.89
6471474697047058101.79
2022081401批1481314781747974103.77102.730.94101.72%～103.74%
2477224773147726103.23
3473374734947343102.40
4479624787547918103.65
5468284696746898101.44
6471404707247106101.89
2022081501批1469064642246664100.94101.500.38101.10%～101.90%
2470684691146990101.64
3467464676146754101.13
4471734695547064101.80
5470024693446968101.59
6470894712247106101.89
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%
113.918004980340808418005979746802070.52
214.048071080378805440.30
单位质量响应值RSD%判断
5766.145736.750.37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
2022081302批186997863498667397.6998.481.1397.32%～99.64%
2896118870889160100.49
386446864988647297.46
487582876988764098.78
587505873658743598.55
686652870998687697.92
2022081401批185525849978526196.1096.163.2792.87%～99.45%
288125869048751498.64
386265867578651197.51
488597885238856099.82
582132820868210992.55
682058817548190692.32
2022081501批186135856128587496.7998.181.6596.49%～99.87%
285484879838673497.76
385619847248517296.00
488076873008768898.83
5870549063188842100.14
690372862738832299.55
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