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%
114.334426144014441764427844185441830.24
214.364416644157441620.02
单位质量响应值RSD%判断
3083.253075.350.19数据可信
供试品溶液-2024042711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%
5min146365-4636595.06794.426.1795.0794.426.17
250001-50001102.522102.52
345576-4557693.44993.45
441284-4128484.64984.65
547300-4730096.98496.98
645773-4577393.85393.85
10min149293-49293101.071100.371.61102.13101.421.65
250297-50297103.129104.27
348888-48888100.240101.28
448107-4810798.63999.58
548291-4829199.016100.09
648827-48827100.115101.16
15min148882-48882100.228100.910.89102.41103.080.86
249392-49392101.274103.56
349598-49598101.696103.85
449683-49683101.870103.91
549180-49180100.839103.02
648550-4855099.547101.70
20min148416-4841699.272100.401.40102.57103.691.32
249028-49028100.527103.94
349411-49411101.312104.59
450064-50064102.651105.82
548271-4827198.975102.27
648607-4860799.664102.93
30min147862-4786298.13699.091.57102.53103.491.50
248829-48829100.119104.65
348671-4867199.795104.20
449407-49407101.304105.61
547455-4745597.302101.70
647748-4774897.903102.27
45min146732-4673295.81997.511.76101.31103.011.68
247721-4772197.847103.49
348717-4871799.890105.41
448328-4832899.092104.53
546805-4680595.969101.45
647023-4702396.416101.87
60min147047-4704796.46596.581.93103.02103.161.81
246798-4679895.955102.68
347668-4766897.739104.37
448470-4847099.383105.92
546842-4684296.045102.59
645780-4578093.867100.40
极限146117-4611794.55895.091.79102.18102.751.66
245721-4572193.746101.54
346933-4693396.232103.94
447789-4778997.987105.63
545652-4565293.605101.22
646046-4604694.413101.98
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%
114.334433544189441144410644332442150.26
214.364403344115440740.14
单位质量响应值RSD%判断
3085.483069.220.38数据可信
供试品溶液-2024042711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%
5min140184-4018482.44694.796.9882.4594.806.97
245906-4590694.18694.19
349475-49475101.508101.51
447222-4722296.88696.89
548149-4814998.78898.79
646279-4627994.95194.95
10min148020-4802098.523100.631.3099.44101.681.35
248599-4859999.711100.76
349539-49539101.640102.77
449690-49690101.950103.03
549033-49033100.602101.70
649389-49389101.332102.39
15min148241-4824198.977100.000.87100.99102.170.92
248807-48807100.138102.29
349464-49464101.486103.74
448799-48799100.121102.33
548714-4871499.947102.16
648415-4841599.334101.51
20min147251-4725196.94598.821.10100.06102.101.14
248393-4839399.288102.56
348810-48810100.144103.53
447989-4798998.460101.78
548377-4837799.256102.58
648164-4816498.819102.10
30min147214-4721496.87097.820.68101.06102.200.74
247878-4787898.232102.60
348153-4815398.796103.29
447620-4762097.703102.12
547702-4770297.871102.30
647505-4750597.467101.85
45min146657-4665795.72795.870.87100.99101.340.86
246955-4695596.338101.80
347293-4729397.032102.63
446061-4606194.504100.01
546677-4667795.768101.28
646724-4672495.864101.33
60min145913-4591394.20094.930.52100.53101.460.59
246171-4617194.730101.26
346634-4663495.680102.35
446255-4625594.902101.45
546384-4638495.167101.75
646254-4625494.900101.43
极限145372-4537293.09093.541.23100.46101.121.17
246616-4661695.643103.23
345825-4582594.020101.76
445121-4512192.575100.18
545406-4540693.160100.80
645198-4519892.733100.32
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%
114.334410744198439294402144093440700.23
214.364413043838439840.47
单位质量响应值RSD%判断
3075.373062.950.29数据可信
供试品溶液-2024042711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%
5min147948-4794898.63898.102.5898.6498.102.58
247346-4734697.39997.40
349271-49271101.359101.36
447931-4793198.60398.60
548071-4807198.89198.89
645539-4553993.68293.68
10min149902-49902102.658100.821.62103.75101.911.61
248809-48809100.409101.49
349714-49714102.271103.40
448307-4830799.376100.47
547926-4792698.59399.69
649386-49386101.596102.64
15min149297-49297101.41399.801.54103.65102.011.52
248660-48660100.103102.30
348739-48739100.265102.53
448679-48679100.142102.34
547085-4708596.86299.06
648623-48623100.026102.20
20min147809-4780998.35297.181.75101.72100.501.72
246219-4621995.08198.39
347886-4788698.510101.89
447964-4796498.671101.98
546197-4619795.03698.31
647347-4734797.401100.68
30min146841-4684196.36197.230.77100.82101.630.74
246846-4684696.371100.74
347527-4752797.772102.24
447734-4773498.198102.61
547358-4735897.424101.75
647288-4728897.280101.64
45min147045-4704596.78095.791.45102.31101.281.42
246116-4611694.869100.31
347402-4740297.515103.07
446678-4667896.025101.53
545514-4551493.63199.04
646639-4663995.945101.39
60min146902-4690296.48694.911.74103.09101.461.70
245701-4570194.015100.51
347058-4705896.807103.45
446374-4637495.400101.97
544935-4493592.44098.89
645849-4584994.320100.83
极限145637-4563793.88493.000.76101.56100.600.75
245453-4545393.505101.04
345301-4530193.192100.91
444912-4491292.392100.02
544722-4472292.00199.48
645224-4522493.034100.59
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