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%
19.734106041093410704114141101410930.08
29.694116241132411470.06
单位质量响应值RSD%判断
4223.334246.340.39数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144722-4472291.12095.023.7791.1295.023.77
249124-49124100.089100.09
345515-4551592.73692.74
445384-4538492.46992.47
546784-4678495.32195.32
648296-4829698.40298.40
10min147798-4779897.38798.151.3398.4099.211.34
249174-49174100.191101.30
348248-4824898.30499.33
447930-4793097.65698.68
547345-4734596.46497.52
648550-4855098.919100.01
15min147255-4725596.28196.371.0198.3898.511.03
247776-4777697.34299.57
347091-4709195.94798.07
447024-4702495.81097.92
546697-4669795.14497.27
647942-4794297.68199.87
20min146531-4653194.80695.801.1297.9799.011.12
247176-4717696.12099.43
346917-4691795.59298.78
447270-4727096.31199.49
546388-4638894.51497.70
647821-4782197.434100.71
30min146008-4600893.74094.401.6497.9698.681.60
247176-4717696.120100.49
346603-4660394.95299.20
446698-4669895.14699.39
544992-4499291.67095.91
646525-4652594.79399.15
45min145474-4547492.65293.342.3697.9198.672.28
246467-4646794.675100.12
346943-4694395.645100.95
445878-4587893.47598.78
543858-4385889.36094.62
646235-4623594.20399.62
极限144944-4494491.57292.481.2197.8698.841.22
246111-4611193.950100.44
345658-4565893.02799.40
445420-4542092.54298.89
544584-4458490.83997.09
645610-4561092.92999.39
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%
113.513742337456375963751937740375470.34
213.473758337520375520.12
单位质量响应值RSD%判断
2779.202787.820.22数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134659-3465978.61787.447.5978.6287.447.59
241444-4144494.00794.01
336380-3638082.52082.52
436884-3688483.66483.66
541101-4110193.22993.23
640835-4083592.62692.63
10min141192-4119293.43596.361.9594.3197.331.97
243202-4320297.99599.04
343166-4316697.91398.83
442499-4249996.40097.33
543031-4303197.60798.64
641798-4179894.81095.84
15min140993-4099392.98495.151.3594.9097.191.39
242401-4240196.17898.31
342070-4207095.42797.43
442004-4200495.27797.28
542557-4255796.53298.65
641654-4165494.48396.57
20min140635-4063592.17294.881.6495.1297.981.64
241417-4141793.94697.15
342392-4239296.15799.22
442339-4233996.03799.10
542218-4221895.76398.96
641978-4197895.21898.35
30min139515-3951589.63192.822.3593.6096.982.30
241552-4155294.25298.50
341986-4198695.23699.37
441676-4167694.53398.66
540464-4046491.78496.04
640343-4034391.51095.70
45min139695-3969590.04092.682.4095.0097.872.34
240954-4095492.89698.19
342622-4262296.679101.87
440754-4075492.44297.62
540842-4084292.64197.92
640291-4029191.39296.60
极限139300-3930089.14491.602.0195.1197.821.97
240513-4051391.89598.22
341538-4153894.220100.49
440791-4079192.52698.73
540528-4052891.92998.24
639626-3962689.88396.11
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%
19.734114141148411724112841162411500.05
29.694108341089410860.02
单位质量响应值RSD%判断
4229.194240.040.19数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147467-4746796.71798.661.3596.7298.661.35
249049-4904999.94199.94
348586-4858698.99799.00
447935-4793597.67197.67
548317-4831798.44998.45
649160-49160100.167100.17
10min148399-4839998.61699.520.9699.69100.620.96
248726-4872699.283100.39
349121-49121100.087101.19
449061-4906199.965101.05
548265-4826598.34399.44
649493-49493100.845101.96
15min148112-4811298.03198.200.85100.20100.400.85
248136-4813698.080100.29
348291-4829198.396100.61
448522-4852298.867101.06
547472-4747296.72798.91
648621-4862199.069101.30
20min147246-4724696.26796.580.4999.5399.870.50
247464-4746496.711100.01
347584-4758496.956100.26
447603-4760396.994100.29
547003-4700395.77299.03
647483-4748396.750100.08
30min146899-4689995.56095.860.7699.89100.230.75
247126-4712696.022100.40
346914-4691495.59099.97
447382-4738296.544100.92
546504-4650494.75599.08
647462-4746296.707101.12
45min146435-4643594.61493.920.88100.0199.350.85
246168-4616894.07099.52
345938-4593893.60299.05
446065-4606593.86199.31
545413-4541392.53297.91
646539-4653994.826100.31
极限145632-4563292.97893.740.7599.42100.210.74
245809-4580993.33999.83
346208-4620894.152100.64
446339-4633994.419100.91
545665-4566593.04699.45
646373-4637394.488101.03
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%
113.513765837664376833764037689376670.06
213.473790437502377030.76
单位质量响应值RSD%判断
2788.082799.030.28数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137976-3797685.83192.535.5185.8392.545.51
242836-4283696.81596.82
341130-4113092.95992.96
438348-3834886.67286.67
542987-4298797.15697.16
642373-4237395.76995.77
10min142792-4279296.71697.811.2097.6798.841.24
243766-4376698.91799.99
343471-4347198.25099.28
442554-4255496.17897.14
543834-4383499.071100.15
643234-4323497.71598.78
15min142656-4265696.40897.400.8598.4499.520.89
243596-4359698.533100.71
343303-4330397.871100.00
442693-4269396.49298.52
543190-4319097.61599.80
643130-4313097.48099.63
20min142060-4206095.06195.830.9798.1699.031.00
242852-4285296.851100.12
342490-4249096.03399.25
441975-4197594.86997.97
542901-4290196.962100.23
642132-4213295.22498.46
30min141150-4115093.00594.341.2397.1698.601.25
242598-4259896.277100.62
341639-4163994.11098.39
441346-4134693.44897.61
541972-4197294.86299.20
641734-4173494.32498.62
45min141356-4135693.47092.881.1698.6698.191.16
241697-4169794.24199.66
340697-4069791.98197.31
440443-4044391.40796.60
541413-4141393.59999.00
640957-4095792.56897.91
极限140560-4056091.67192.480.7897.9098.820.83
241299-4129993.34199.80
340813-4081392.24398.59
440687-4068791.95898.17
541315-4131593.37799.81
640825-4082592.27098.64
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%
19.734127941293412384130041302412820.07
29.694102641173411000.26
单位质量响应值RSD%判断
4242.754241.490.03数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148217-4821798.07198.621.1098.0798.621.10
249259-49259100.191100.19
348863-4886399.38599.39
447896-4789697.41997.42
548022-4802297.67597.67
648656-4865698.96498.96
10min149090-4909099.84799.421.18100.94100.521.17
249394-49394100.465101.58
348426-4842698.49799.60
448346-4834698.33499.42
548381-4838198.40599.49
649652-49652100.990102.09
15min148187-4818798.01097.760.99100.2199.960.99
248513-4851398.673100.90
348543-4854398.734100.93
447838-4783897.30199.48
547268-4726896.14198.32
648041-4804197.71399.94
20min148065-4806597.76296.411.45101.0599.701.43
247848-4784897.321100.65
347415-4741596.44099.74
447134-4713495.86999.12
546171-4617193.91097.16
647762-4776297.146100.45
30min147884-4788497.39496.160.76101.77100.520.74
247209-4720996.021100.43
346975-4697595.54599.91
447431-4743196.473100.79
546892-4689295.37699.67
647270-4727096.145100.53
45min146776-4677695.14094.420.76100.6099.850.76
246586-4658694.754100.23
346387-4638794.34999.78
446504-4650494.58799.98
545762-4576293.07898.43
646531-4653194.642100.10
极限145817-4581793.19093.200.5299.7099.680.47
245891-4589193.34099.87
345364-4536492.26998.75
445959-4595993.47999.92
546013-4601393.58999.97
645895-4589593.34999.86
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%
113.513754637683375643753537591375840.16
213.473746937509374890.08
单位质量响应值RSD%判断
2781.942783.150.04数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138724-3872487.86892.333.4887.8792.343.48
241482-4148294.12694.13
341036-4103693.11493.11
439120-3912088.76688.77
541786-4178694.81694.82
642003-4200395.30895.31
10min142950-4295097.45796.741.2698.4397.761.27
243014-4301497.60298.65
342427-4242796.27097.30
441652-4165294.51195.50
543064-4306497.71598.77
642687-4268796.86097.92
15min142199-4219995.75395.650.9097.8197.750.91
242461-4246196.34798.48
342528-4252896.49998.60
441507-4150794.18296.22
541945-4194595.17697.32
642283-4228395.94398.08
20min142088-4208895.50194.311.1998.6297.481.17
241780-4178094.80298.00
341484-4148494.13097.31
440921-4092192.85395.94
541068-4106893.18696.38
642049-4204995.41298.61
30min140890-4089092.78293.470.9496.9797.680.92
240800-4080092.57896.83
341167-4116793.41197.63
441012-4101293.05997.17
541795-4179594.83699.07
641498-4149894.16298.42
45min141178-4117893.43692.460.6798.6597.710.65
240712-4071292.37997.66
340807-4080792.59497.85
440343-4034391.54196.69
540653-4065392.24597.53
640794-4079492.56597.87
极限140138-4013891.07691.220.9697.3397.500.93
240053-4005390.88397.19
339895-3989590.52596.81
439913-3991390.56696.73
540928-4092892.86999.18
640288-4028891.41697.75
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%
19.734114541100411164104541075410960.10
29.694104641155411000.19
单位质量响应值RSD%判断
4223.644241.490.30数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148355-4835598.57599.200.9998.5799.190.99
248123-4812398.10298.10
348683-4868399.24399.24
448464-4846498.79798.80
549497-49497100.903100.90
648835-4883599.55399.55
10min148200-4820098.25998.650.5799.3599.760.56
248372-4837298.60999.70
348632-4863299.139100.24
448086-4808698.02699.12
548273-4827398.40799.53
648802-4880299.486100.59
15min147286-4728696.39597.020.6798.5899.220.66
247256-4725696.33498.52
347918-4791897.68499.89
447619-4761997.07499.26
548006-4800697.863100.08
647472-4747296.77598.99
20min147190-4719096.20096.440.8999.4699.720.88
246710-4671095.22198.48
347809-4780997.462100.75
447137-4713796.09299.36
547778-4777897.398100.70
647224-4722496.26999.56
30min146680-4668095.16095.061.0399.4999.411.01
246434-4643494.65998.97
346317-4631794.42098.79
446119-4611994.01698.35
547486-4748696.803101.19
646763-4676395.32999.69
45min146147-4614794.07394.250.9899.4699.660.96
245763-4576393.29198.66
346329-4632994.44599.87
445968-4596893.70999.09
547075-4707595.965101.42
646133-4613394.04599.46
极限145883-4588393.53593.320.7799.9699.780.70
245568-4556892.89399.30
346078-4607893.933100.40
446268-4626894.320100.74
545421-4542192.59499.12
645457-4545792.66799.13
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%
113.513735437354375043740337380373990.17
213.473741137407374090.01
单位质量响应值RSD%判断
2768.252777.210.23数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138431-3843187.51289.131.2487.5189.131.24
239284-3928489.45489.45
339368-3936889.64589.65
438925-3892588.63788.64
539864-3986490.77590.77
638972-3897288.74488.74
10min141297-4129794.03894.051.2195.0195.041.19
241474-4147494.44195.43
341938-4193895.49896.49
440888-4088893.10794.09
540585-4058592.41793.43
641634-4163494.80595.79
15min141115-4111593.62493.700.9195.6495.740.90
240835-4083592.98695.03
341877-4187795.35997.42
441041-4104193.45595.47
540936-4093693.21695.25
641087-4108793.56095.60
20min141227-4122793.87993.961.1096.9497.041.08
240751-4075192.79595.87
342070-4207095.79898.91
440951-4095193.25096.31
541214-4121493.84996.92
641364-4136494.19197.27
30min141169-4116993.74693.160.8497.8597.280.82
240712-4071292.70696.81
340923-4092393.18697.37
440331-4033191.83895.93
541098-4109893.58597.70
641241-4124193.91098.04
45min140088-4008891.28592.150.9896.4397.310.95
240151-4015191.42896.57
340905-4090593.14598.36
440166-4016691.46396.58
540961-4096193.27398.43
640549-4054992.33597.50
极限140215-4021591.57491.361.2297.7397.541.17
240146-4014691.41797.57
340919-4091993.17799.43
440066-4006691.23597.37
539396-3939689.70995.90
639975-3997591.02897.22
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%
19.734121741160410874109341110411330.14
29.694119941077411380.21
单位质量响应值RSD%判断
4227.444245.410.30数据可信
-供试品溶液-2024052721批-培哚普利-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146106-4610693.90496.282.0193.9096.282.01
248766-4876699.32299.32
347556-4755696.85796.86
446433-4643394.57094.57
547165-4716596.06196.06
647597-4759796.94196.94
10min146463-4646394.63195.841.5795.6796.911.57
248442-4844298.66299.77
346983-4698395.69096.77
446564-4656494.83795.89
547225-4722596.18397.25
646672-4667295.05796.13
15min146071-4607193.83395.221.7495.9397.361.74
248016-4801697.79499.99
347382-4738296.50398.64
446021-4602193.73195.84
546834-4683495.38797.52
646201-4620194.09896.23
20min145154-4515491.96593.981.7395.1097.181.73
247099-4709995.92799.21
346488-4648894.68297.89
445213-4521392.08595.23
546693-4669395.10098.30
646227-4622794.15197.33
30min144706-4470691.05392.451.8695.2196.691.85
246885-4688595.49199.84
345712-4571293.10297.37
444705-4470591.05195.22
545481-4548192.63196.88
644875-4487591.39795.62
45min143819-4381989.24692.292.2194.4297.562.17
246825-4682595.369100.78
345677-4567793.03098.33
444906-4490691.46096.64
545617-4561792.90898.19
645048-4504891.74996.99
极限143886-4388689.38391.281.7695.5597.571.75
245938-4593893.562100.04
344677-4467790.99497.33
444015-4401589.64595.84
545105-4510591.86598.18
645274-4527492.21098.47
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%
113.513736937429374043740237520374250.16
213.473725437412373330.30
单位质量响应值RSD%判断
2770.172771.570.04数据可信
-供试品溶液-2024052721批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136128-3612882.32389.235.1882.3289.235.18
240758-4075892.87392.87
339919-3991990.96190.96
439184-3918489.28689.29
537487-3748785.41985.42
641480-4148094.51894.52
10min139894-3989490.90492.333.3891.8293.323.38
241773-4177395.18596.22
340673-4067392.67993.69
441068-4106893.57994.57
538098-3809886.81187.76
641610-4161094.81495.86
15min139126-3912689.15491.933.5891.0893.943.59
241570-4157094.72396.81
341389-4138994.31096.35
440902-4090293.20195.23
538001-3800186.59088.50
641076-4107693.59795.70
20min138767-3876788.33690.523.0191.2593.563.03
240728-4072892.80495.95
340704-4070492.75095.84
439936-3993691.00094.07
537801-3780186.13589.01
640420-4042092.10295.25
30min138594-3859487.94289.563.1991.8493.603.20
240739-4073992.82997.00
339623-3962390.28694.41
439657-3965790.36494.44
537176-3717684.71188.54
640034-4003491.22395.39
45min136703-3670383.63388.964.1588.5194.004.10
240469-4046992.21497.42
339908-3990890.93696.06
439959-3995991.05296.13
537267-3726784.91889.69
639946-3994691.02296.20
极限138791-3879188.39189.013.1694.1995.043.16
239957-3995791.04797.28
339131-3913189.16595.30
439257-3925789.45295.55
536851-3685183.97089.69
640394-4039492.04398.24
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