坎地沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234440244190443214432044257442980.18
214.304410344462442820.58
单位质量响应值RSD%判断
3113.003096.640.38数据可信
长期3月-供试品溶液-8145795批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142869-4286987.17787.394.9587.1887.394.95
246289-4628994.13194.13
340767-4076782.90282.90
444089-4408989.65889.66
540649-4064982.66282.66
643191-4319187.83187.83
10min148111-4811197.83797.373.7698.8198.343.77
249355-49355100.366101.41
346085-4608593.71794.64
447945-4794597.49998.50
545583-4558392.69693.61
650218-50218102.121103.10
15min149526-49526100.714100.153.66102.77102.203.67
250497-50497102.689104.85
347148-4714895.87897.84
450173-50173102.030104.11
546916-4691695.40697.35
651222-51222104.163106.27
20min147879-4787997.36597.093.96100.54100.263.96
249256-49256100.165103.47
345789-4578993.11596.14
448811-4881199.260102.47
545096-4509691.70594.71
649635-49635100.936104.20
30min148908-4890899.45797.833.48103.71102.073.49
249185-49185100.021104.44
346151-4615193.85197.91
448398-4839898.420102.74
545968-4596893.47997.51
650030-50030101.739106.13
45min148389-4838998.40296.862.99103.76102.193.02
248450-4845098.526104.05
346043-4604393.63198.74
448408-4840898.441103.85
545602-4560292.73497.80
648890-4889099.421104.94
60min146702-4670294.97195.922.82101.43102.322.86
248811-4881199.260105.88
346007-4600793.55899.70
447145-4714595.872102.38
545657-4565792.84698.94
648681-4868198.996105.62
极限146717-4671795.00295.972.72102.51103.442.77
248989-4898999.622107.35
345799-4579993.135100.32
447790-4779097.184104.75
545846-4584693.231100.36
648011-4801197.633105.36
坎地沙坦酯左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234411844027439034407144075440390.19
214.304456244025442940.86
单位质量响应值RSD%判断
3094.803097.480.07数据可信
加速3月-供试品溶液-8145795批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min139750-3975081.06079.114.2381.0679.114.23
236237-3623773.89673.90
340587-4058782.76782.77
437445-3744576.36076.36
539008-3900879.54779.55
639740-3974081.04081.04
10min145759-4575993.31492.972.3394.2193.842.34
244369-4436990.47991.30
345954-4595493.71294.63
444318-4431890.37591.22
547036-4703695.91896.80
646095-4609593.99994.90
15min146900-4690095.64195.762.1397.5897.682.14
246237-4623794.28996.12
347314-4731496.48598.45
445435-4543592.65394.51
548163-4816398.216100.17
647713-4771397.29999.24
20min145003-4500391.77291.182.2994.7794.152.29
243789-4378989.29792.17
344694-4469491.14294.18
443324-4332488.34891.23
546107-4610794.02497.06
645354-4535492.48895.51
30min145388-4538892.55792.721.9596.5896.711.96
244775-4477591.30795.17
345837-4583793.47397.52
444316-4431690.37194.24
546854-4685495.54799.63
645648-4564893.08897.14
45min145208-4520892.19092.741.2397.2497.761.26
245410-4541092.60297.48
345587-4558792.96398.05
444577-4457790.90495.77
545947-4594793.69798.84
646142-4614294.09599.18
60min145873-4587393.54692.471.3399.6298.521.35
245019-4501991.80597.71
345269-4526992.31598.43
444403-4440390.54996.43
545460-4546092.70498.89
646061-4606193.930100.06
极限144979-4497991.72391.641.9998.8498.711.93
244942-4494291.64898.58
344313-4431390.36597.51
443776-4377689.27096.15
545200-4520092.17499.39
646407-4640794.635101.81
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