培哚普利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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974066840853406634060140679406930.24
210.034053540530405320.01
单位质量响应值RSD%判断
4081.544041.080.71数据可信
供试品溶液-2024052721批-培哚普利-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%
5min147194-47194100.26799.321.95100.2799.321.95
246621-4662199.04999.05
345439-4543996.53896.54
447993-47993101.964101.96
546058-4605897.85397.85
647187-47187100.252100.25
10min146248-4624898.257100.461.7199.37101.561.70
247181-47181100.239101.34
346868-4686899.574100.65
448057-48057102.100103.23
546942-4694299.731100.82
648408-48408102.846103.96
15min147018-4701899.89399.341.19102.10101.561.20
246166-4616698.083100.30
346355-4635598.484100.66
447497-47497100.910103.18
546303-4630398.374100.57
647219-47219100.320102.58
20min146157-4615798.06398.241.19101.38101.571.20
246213-4621398.182101.49
345544-4554496.761100.03
446788-4678899.404102.79
545791-4579197.286100.57
646958-4695899.765103.14
30min145621-4562196.92597.321.77101.33101.741.68
245053-4505395.718100.11
345620-4562096.923101.27
446016-4601697.764102.26
547314-47314100.522104.89
645232-4523296.098100.58
45min145468-4546896.60096.981.90102.08102.481.83
244643-4464394.847100.31
344814-4481495.210100.64
445832-4583297.373102.95
546953-4695399.755105.24
646167-4616798.085103.63
极限144423-4442394.38095.632.30100.94102.212.21
244077-4407793.644100.16
343932-4393293.33699.82
445551-4555196.776103.44
546559-4655998.918105.51
645541-4554196.755103.39
培哚普利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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.293914939252392113919439211392030.10
214.293900438995390000.02
单位质量响应值RSD%判断
2743.392729.180.37数据可信
供试品溶液-2024052721批-左氨氯地平-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%
5min131877-3187773.55570.403.5073.5570.403.50
231142-3114271.85971.86
328819-2881966.49866.50
430987-3098771.50171.50
530032-3003269.29769.30
630204-3020469.69469.69
10min135875-3587582.78084.562.0183.6085.341.99
236741-3674184.77885.58
336160-3616083.43784.18
436883-3688385.10685.90
536273-3627383.69884.47
637935-3793587.53388.31
15min137027-3702785.43884.851.3687.1886.581.36
236385-3638583.95785.70
336437-3643784.07785.74
436947-3694785.25386.99
536274-3627483.70085.40
637571-3757186.69388.44
20min136519-3651984.26683.961.7086.9586.621.68
236506-3650684.23686.91
336027-3602783.13185.73
435851-3585182.72485.41
535912-3591282.86585.50
637499-3749986.52789.24
30min136331-3633183.83284.171.6287.4587.771.54
235907-3590782.85486.46
336392-3639283.97387.50
436018-3601883.11086.72
537539-3753986.61990.17
636683-3668384.64488.32
45min136404-3640484.00084.001.8188.5588.531.75
235917-3591782.87787.41
335586-3558682.11386.57
436173-3617383.46788.00
537295-3729586.05690.57
637041-3704185.47090.08
极限138814-3881489.56189.382.7595.0594.852.64
237619-3761986.80492.25
337440-3744086.39191.76
438822-3882289.58095.04
540173-4017392.69798.17
639552-3955291.26496.83
培哚普利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DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.974053540484406434050140468405260.18
210.034063140565405980.12
单位质量响应值RSD%判断
4064.794047.660.30数据可信
供试品溶液-2024052721批-培哚普利-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%
5min147339-47339100.699100.690.77100.70100.690.77
246808-4680899.56999.57
347337-47337100.695100.69
447286-47286100.586100.59
547293-47293100.601100.60
647949-47949101.996102.00
10min147970-47970102.041102.090.88103.16103.200.87
248738-48738103.675104.78
347558-47558101.165102.28
447788-47788101.654102.77
547741-47741101.554102.67
648156-48156102.437103.57
15min147345-47345100.712100.590.58102.96102.840.57
246968-4696899.910102.17
347001-4700199.980102.22
447309-47309100.635102.88
547404-47404100.837103.08
647703-47703101.473103.74
20min146338-4633898.56998.501.83101.94101.871.77
245937-4593797.716101.08
345134-4513496.00899.36
446312-4631298.514101.88
547735-47735101.541104.91
646369-4636998.635102.03
30min145654-4565497.11497.210.63101.58101.680.60
245653-4565397.112101.57
345980-4598097.808102.23
445182-4518296.110100.57
545875-4587597.585102.08
645852-4585297.536102.03
45min145081-4508195.89694.251.39101.4499.801.29
244399-4439994.44599.98
344871-4487195.449100.96
443846-4384693.26998.80
544194-4419494.00999.59
643459-4345992.44598.02
极限145095-4509595.92594.241.09102.54100.841.03
243942-4394293.473100.06
344139-4413993.892100.46
444373-4437394.390100.95
544538-4453894.741101.36
643740-4374093.04399.65
培哚普利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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.293900139053390753890539129390330.22
214.293909539092390940.01
单位质量响应值RSD%判断
2731.492735.760.12数据可信
供试品溶液-2024052721批-左氨氯地平-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%
5min130673-3067370.84572.301.6670.8472.301.66
232028-3202873.97473.97
330788-3078871.11071.11
431656-3165673.11573.12
531445-3144572.62872.63
631222-3122272.11372.11
10min136612-3661284.56285.431.6085.3586.241.59
237770-3777087.23788.06
336729-3672984.83285.62
436859-3685985.13385.94
536310-3631083.86584.67
637656-3765686.97387.77
15min136943-3694385.32785.530.9687.0587.290.96
237268-3726886.07787.87
336932-3693285.30187.03
437195-3719585.90987.67
536424-3642484.12885.87
637433-3743386.45888.23
20min136068-3606883.30683.691.2385.9886.401.21
236367-3636783.99686.74
335416-3541681.80084.48
436509-3650984.32487.04
536420-3642084.11986.79
636634-3663484.61387.34
30min135729-3572982.52383.231.2586.1286.861.23
236579-3657984.48688.17
336008-3600883.16786.76
435681-3568182.41286.06
535616-3561682.26285.87
636597-3659784.52788.20
45min135560-3556082.13281.351.1186.6585.901.05
235670-3567082.38687.01
335447-3544781.87186.38
434788-3478880.34984.91
535049-3504980.95285.47
634808-3480880.39585.00
极限137762-3776287.21887.770.5192.6593.230.51
238196-3819688.22193.76
337783-3778387.26792.69
437999-3799987.76693.22
538170-3817088.16193.58
638101-3810188.00193.50
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