缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.112483122486632482742486442488522485490.10
2 14.042476352474332475340.06
单位质量响应值RSD%判断
17615.1017630.630.07数据可信
供试品溶液-2批-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193219-9321934.29035.735.2734.2935.735.27
294040-9404034.59234.59
391936-9193633.81833.82
496801-9680135.60835.61
5103099-10309937.92537.92
6103702-10370238.14638.15
10min1172161-17216163.32962.634.9163.3962.694.91
2170421-17042162.68962.75
3153814-15381456.58056.64
4173610-17361063.86263.92
5176952-17695265.09165.15
6174603-17460364.22764.29
15min1196506-19650672.28473.604.1472.4573.774.14
2202349-20234974.43374.60
3186117-18611768.46368.61
4207568-20756876.35376.52
5208611-20861176.73776.91
6199403-19940373.35073.52
20min1213486-21348678.53078.704.5678.8178.984.56
2213890-21389078.67978.96
3196165-19616572.15972.42
4224960-22496082.75183.04
5215293-21529379.19579.49
6219934-21993480.90281.19
30min1228884-22888484.19484.883.4584.6185.293.45
2232692-23269285.59586.01
3215567-21556779.29679.68
4237072-23707287.20687.64
5235291-23529186.55186.98
6234925-23492586.41686.84
45min1239238-23923888.00388.644.3188.5689.204.31
2240151-24015188.33988.90
3222037-22203781.67682.19
4251820-25182092.63193.21
5246660-24666090.73391.31
6245981-24598190.48391.06
60min1241939-24193988.99690.363.4289.7091.063.42
2246218-24621890.57091.28
3232126-23212685.38786.04
4257665-25766594.78195.51
5248356-24835691.35792.08
6247527-24752791.05291.77
极限1250458-25045892.13092.824.7092.9893.684.70
2256174-25617494.23395.09
3229901-22990184.56885.36
4262421-26242196.53197.42
5261084-26108496.03996.92
6254036-25403693.44694.32
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.504627871462791546291164627219462747946279200.02
215.614610988460650246087450.07
单位质量响应值RSD%判断
298575.48295243.110.80数据可信
供试品溶液-2批-缬沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14280996-428099680.37783.122.5880.3883.122.58
24362068-436206881.89981.90
34483860-448386084.18684.19
44498131-449813184.45484.45
54586736-458673686.11786.12
64351507-435150781.70181.70
10min14919191-491919192.35995.372.1292.4995.512.12
25013546-501354694.13194.27
35133251-513325196.37896.52
45195577-519557797.54897.69
55177336-517733697.20697.35
65039549-503954994.61994.76
15min15003751-500375193.94796.672.0194.2396.962.01
25073581-507358195.25895.55
35200172-520017297.63597.94
45267936-526793698.90799.21
55238321-523832198.35198.66
65108257-510825795.90996.20
20min15010829-501082994.08096.852.1294.5297.302.12
25075618-507561895.29695.75
35206563-520656397.75598.22
45292689-529268999.37299.84
55249750-524975098.56599.03
65113821-511382196.01396.47
30min15016702-501670294.19097.002.2794.7997.632.27
25068128-506812895.15595.77
35218716-521871697.98398.61
45324119-532411999.962100.60
55250276-525027698.57599.21
65121719-512171996.16296.78
45min15022056-502205694.29097.252.4295.0598.032.42
25091489-509148995.59496.36
35215913-521591397.93098.72
45362089-5362089100.675101.48
55265522-526552298.86299.66
65120754-512075496.14496.92
60min15024633-502463394.33997.362.4795.2598.302.47
25097283-509728395.70396.63
35225673-522567398.11399.07
45371774-5371774100.856101.82
55273387-527338799.00999.97
65120054-512005496.13097.06
极限15070066-507006695.19297.802.4196.2698.902.41
25113425-511342596.00697.09
35250208-525020898.57499.69
45377741-5377741100.969102.10
55320556-532055699.895101.02
65122386-512238696.17497.27
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