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%
113.972460712460712453282446942449812454290.26
213.942492902494182493540.04
单位质量响应值RSD%判断
17568.2917887.661.28数据可信
供试品溶液-25031801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%
15min11030761-1030761376.944376.062.21376.94376.062.21
21004511-1004511367.345367.34
31049753-1049753383.890383.89
5min11002120-1002120366.471370.320.99367.10370.950.99
21013842-1013842370.757371.37
31022000-1022000373.741374.38
10min1232644-23264485.07787.092.0186.3288.341.99
2241096-24109688.16889.40
3240745-24074588.03989.30
20min1235831-23583186.24286.920.6987.6288.310.68
2238823-23882387.33688.71
3238395-23839587.18088.59
30min1255483-25548393.42994.541.3894.9596.071.37
2257656-25765694.22495.75
3262413-26241395.96397.52
45min1252177-25217792.22093.291.3593.9094.991.35
2254274-25427492.98794.67
3258896-25889694.67796.39
60min1249514-24951491.24693.922.4993.0895.772.45
2261163-26116395.50697.34
3259836-25983695.02196.89
极限1250378-25037891.56292.881.2793.5594.881.26
2255010-25501093.25695.25
3256545-25654593.81795.85
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%
116.329453278945213694402699430067943072894412960.12
216.389587189959566595914270.07
单位质量响应值RSD%判断
578510.78585557.200.86数据可信
供试品溶液-25031801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%
15min13928630-392863037.62738.061.0337.6338.061.03
23982968-398296838.14838.15
34008204-400820438.39038.39
5min13943644-394364437.77137.820.9037.8337.880.90
23986435-398643538.18138.24
33916048-391604837.50737.57
10min18570931-857093182.09083.371.3482.2283.501.34
28763845-876384583.93884.07
38779273-877927384.08684.21
20min18554709-855470981.93583.151.6982.2083.421.68
28649314-864931482.84183.11
38841083-884108384.67884.94
30min19522993-952299391.20992.531.2691.6192.931.25
29749442-974944293.37893.78
39709069-970906992.99193.40
45min19483478-948347890.83091.661.0991.3892.221.09
29541494-954149491.38691.95
39685335-968533592.76493.33
60min19604989-960498991.99493.281.2292.7094.001.22
29829198-982919894.14294.85
39785067-978506793.71994.44
极限19576892-957689291.72592.691.0892.5893.561.08
29672489-967248992.64193.51
39784585-978458593.71494.59
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%
113.972462772465482462202465522465662464330.07
213.942494992493492494240.05
单位质量响应值RSD%判断
17640.1617892.681.01数据可信
供试品溶液-25031802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%
15min1-0.000247.4786.630.00247.4786.63
21030793-1030793376.129376.13
31003829-1003829366.290366.29
5min11030299-1030299375.949378.480.74375.95378.890.82
21045442-1045442381.474382.10
31035932-1035932378.004378.61
10min1232351-23235184.78385.200.7585.4186.241.04
2235499-23549985.93287.19
3232619-23261984.88186.12
20min1235771-23577186.03187.371.4886.8088.561.83
2239774-23977487.49288.90
3242789-24278988.59289.97
30min1251741-25174191.85892.440.6592.7793.770.99
2255004-25500493.04994.60
3253228-25322892.40193.93
45min1253997-25399792.68293.710.9793.7595.201.34
2258705-25870594.40096.11
3257762-25776294.05595.74
60min1254892-25489293.00893.910.8694.2395.561.23
2259131-25913194.55596.42
3258106-25810694.18196.02
极限1255612-25561293.27194.741.4394.6496.531.77
2262924-26292495.93997.96
3260336-26033694.99596.99
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%
116.329478363948474694870129497829950113594898170.10
216.389585418959766295915400.10
单位质量响应值RSD%判断
581483.88585564.100.50数据可信
供试品溶液-25031802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%
15min11000679-10006799.56020.1845.619.5620.1845.61
22632137-263213725.14525.14
32703586-270358625.82825.83
5min12700677-270067725.80025.793.3925.8225.823.37
22607191-260719124.90724.95
32789787-278978726.65126.69
10min17531424-753142471.94872.551.3672.0172.631.37
27714041-771404173.69373.78
37539250-753925072.02372.11
20min17961549-796154976.05775.561.7176.2475.761.70
27756907-775690774.10274.31
38011353-801135376.53376.74
30min19374575-937457589.55689.930.7489.8690.260.75
29494283-949428390.70091.03
39372902-937290289.54089.88
45min19552913-955291391.26091.320.0991.7191.790.10
29568558-956855891.40991.89
39556278-955627891.29291.78
60min19764677-976467793.28393.570.5093.8994.200.51
29851602-985160294.11394.75
39769059-976905993.32493.96
极限19862611-986261194.21894.440.4094.9895.230.41
29931431-993143194.87695.67
39864706-986470694.23895.03
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%
113.972510292510472513192506472498822507850.23
213.942478722478782478750.01
单位质量响应值RSD%判断
17951.6817781.560.68数据可信
供试品溶液-APCE853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%
15min1899792-899792326.477335.452.58326.48335.452.58
2926417-926417336.138336.14
3947368-947368343.739343.74
5min1224340-22434081.39980.411.0981.9480.971.07
2219809-21980979.75580.31
3220699-22069980.07880.65
10min1241718-24171887.70488.921.1988.3889.611.20
2246556-24655689.45990.15
3246949-24694989.60290.31
20min1232248-23224884.26888.844.6185.0989.684.58
2253969-25396992.14992.99
3248337-24833790.10690.96
30min1250617-25061790.93390.821.3891.9091.811.36
2253595-25359592.01393.01
3246732-24673289.52390.53
45min1252834-25283491.73791.460.5492.8692.600.52
2252832-25283291.73792.89
3250508-25050890.89392.05
60min1253337-25333791.92091.320.6793.1992.610.64
2251698-25169891.32592.63
3249991-24999190.70692.01
极限1248438-24843890.14290.320.7291.5791.770.71
2250891-25089191.03292.49
3247441-24744189.78191.24
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%
116.329621498962982196382989626427961302696258140.10
216.389497904950427795010900.05
单位质量响应值RSD%判断
589817.03580042.121.19数据可信
供试品溶液-APCE853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%
15min12664215-266421525.39223.988.5925.3923.988.59
22616373-261637324.93624.94
32268519-226851921.62021.62
5min17881793-788179375.11975.831.5175.1675.871.51
28095203-809520377.15377.19
37893364-789336475.22975.26
10min19526075-952607590.79091.370.8590.9691.540.85
29679067-967906792.24892.42
39555363-955536391.06991.23
20min19999146-999914695.29895.290.5495.6295.610.54
210051163-1005116395.79496.12
39943898-994389894.77295.09
30min110088246-1008824696.14896.030.6596.6396.510.65
210133460-1013346096.57997.06
310005171-1000517195.35695.83
45min110115830-1011583096.41196.220.6197.0596.850.61
210143996-1014399696.67997.32
310026675-1002667595.56196.19
60min110280402-1028040297.97996.761.2598.7897.561.24
210149664-1014966496.73397.54
310028290-1002829095.57696.37
极限110089088-1008908896.15696.030.5997.1296.990.59
210126535-1012653596.51397.48
310011736-1001173695.41896.37
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