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%
19.952089921047211142109820985210290.42
210.142151121352214320.53
单位质量响应值RSD%判断
2113.472113.610.01数据可信
加速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
20251104211252952538325339102.29101.161.4499.63%～102.68%
2248152477924797100.10
3250932563625364102.39
424493244582447698.81
5252522537525314102.19
6250532506225058101.15
20251105211247352486024798100.11100.740.9499.76%～101.73%
2250672490624986100.86
3252982543825368102.41
4248802510624993100.89
5247352508224908100.55
624582247892468699.65
20251106211251302566925400102.54101.881.47100.31%～103.45%
2251522488725020101.00
3253142517125242101.90
424780247002474099.87
5260182566125840104.31
6251942517725186101.67
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%
113.548088081197814188129180901811370.30
213.658159382228819100.55
单位质量响应值RSD%判断
5992.396000.730.10数据可信
加速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
2025110421190963936649231499.7998.031.9096.08%～99.98%
288889884818868595.87
391055903039067998.03
488578884368850795.68
591326919759165099.08
692309922049225699.73
2025110521189504897658963496.9097.460.5696.90%～98.03%
289981902809013097.43
390955910199098798.36
489761896998973097.00
590476903789042797.76
689897901459002197.32
2025110621191625904599104298.4298.601.2297.34%～99.85%
291048915689130898.71
390901908369086898.23
489455897438959996.86
5928789318693032100.57
692024907319137898.78
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