培哚普利左氨氯地平项目信息
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%
19.604007440099401224006940073400870.06
29.584017140152401620.04
单位质量响应值RSD%判断
4175.734192.280.28数据可信
中间条件3月-供试品溶液-24050602批-培哚普利-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%
5min148058-4805899.10698.341.6199.1198.341.61
247885-4788598.74998.75
346167-4616795.20795.21
448129-4812999.25399.25
547704-4770498.37698.38
648182-4818299.36299.36
10min148106-4810699.20598.041.63100.3199.131.63
247787-4778798.54799.64
346171-4617195.21596.27
448126-4812699.246100.35
547074-4707497.07798.17
647972-4797298.929100.03
15min148359-4835999.72797.211.92101.9399.391.91
247191-4719197.31899.51
345586-4558694.00896.12
447362-4736297.67199.88
546944-4694496.80998.98
647396-4739697.74199.94
20min147012-4701296.94995.531.88100.2698.791.86
245543-4554393.92097.19
345089-4508992.98396.14
446473-4647395.83899.13
546448-4644895.78699.03
647383-4738397.714101.00
30min146195-4619595.26494.351.5099.6598.681.50
245635-4563594.10998.43
344541-4454191.85396.05
446441-4644195.772100.13
545567-4556793.96998.28
646142-4614295.15599.53
45min145328-4532893.47692.611.9198.9297.981.89
244644-4464492.06697.43
343518-4351889.74494.96
445551-4555193.93699.36
544528-4452891.82797.18
645871-4587194.596100.03
极限145432-4543293.69192.521.78100.1898.921.77
245247-4524793.30999.69
343323-4332389.34295.55
445183-4518393.17799.64
544687-4468792.15498.53
645304-4530493.42799.91
培哚普利左氨氯地平项目信息
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%
113.693757937586375343755337605375710.08
213.653768037679376800.01
单位质量响应值RSD%判断
2744.412760.440.42数据可信
中间条件3月-供试品溶液-24050602批-左氨氯地平-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%
5min142027-4202796.40797.283.6396.4197.283.63
242475-4247597.43497.43
345430-45430104.213104.21
441472-4147295.13495.13
541349-4134994.85194.85
641694-4169495.64395.64
10min143067-4306798.79298.833.9199.8699.913.90
242728-4272898.01599.10
346354-46354106.332107.49
442326-4232697.09398.15
541554-4155495.32296.38
642463-4246397.40798.47
15min142845-4284598.28398.073.63100.45100.253.63
242510-4251097.51599.69
345756-45756104.961107.30
441817-4181795.92598.06
541495-4149595.18697.30
642086-4208696.54298.69
20min141997-4199796.33896.443.9699.6099.713.95
241160-4116094.41897.67
345295-45295103.903107.41
440866-4086693.74396.95
541002-4100294.05597.23
641933-4193396.19199.41
30min141072-4107294.21694.873.8298.5599.213.82
241005-4100594.06298.37
344482-44482102.038106.70
440733-4073393.43897.68
539999-3999991.75595.97
640858-4085893.72598.01
45min140519-4051992.94793.323.7298.3398.723.72
240619-4061993.17798.53
343481-4348199.742105.54
439818-3981891.33996.62
538999-3899989.46194.70
640659-4065993.26998.60
极限140161-4016192.12692.793.5898.5499.223.58
240500-4050092.90499.29
343218-4321899.139106.04
439483-3948390.57196.87
539158-3915889.82596.05
640172-4017292.15198.52
培哚普利左氨氯地平项目信息
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%
19.604019440217402204024040191402120.06
29.584008840031400600.11
单位质量响应值RSD%判断
4188.754181.630.13数据可信
中间条件3月-供试品溶液-24050701批-培哚普利-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%
5min146902-4690296.69597.422.2596.6997.422.25
246904-4690496.69996.70
347272-4727297.45797.46
447976-4797698.90998.91
545672-4567294.15994.16
648783-48783100.572100.57
10min147159-4715997.22497.822.1998.3098.902.19
247069-4706997.03998.11
347364-4736497.64798.73
448242-4824299.457100.56
545929-4592994.68995.73
648930-48930100.875101.99
15min147020-4702096.93897.342.1799.0999.512.16
246833-4683396.55298.70
346594-4659496.06098.23
448277-4827799.529101.73
545959-4595994.75096.85
648605-48605100.205102.44
20min146058-4605894.95495.862.6398.1999.112.61
246073-4607394.98598.21
346076-4607694.99298.23
446919-4691996.730100.04
545147-4514793.07696.23
648710-48710100.422103.77
30min146043-4604394.92494.012.1199.2198.322.11
245197-4519793.17997.46
344900-4490092.56796.86
446136-4613695.11599.50
544338-4433891.40895.59
646974-4697496.843101.31
45min144681-4468192.11693.142.3397.4698.502.32
244884-4488492.53497.85
344772-4477292.30397.62
445880-4588094.588100.03
543945-4394590.59895.80
646907-4690796.705102.25
极限144832-4483292.42792.772.5198.7999.172.49
244514-4451491.77198.12
344474-4447491.68998.03
445750-4575094.320100.81
543610-4361089.90896.12
646823-4682396.532103.15
培哚普利左氨氯地平项目信息
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%
113.693758737628376043763137608376120.05
213.653747437474374740.00
单位质量响应值RSD%判断
2747.412745.350.06数据可信
中间条件3月-供试品溶液-24050701批-左氨氯地平-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%
5min140389-4038992.85295.443.1692.8595.443.16
242870-4287098.55698.56
343383-4338399.73699.74
440249-4024992.53192.53
541124-4112494.54294.54
641062-4106294.40094.40
10min141710-4171095.88997.722.7496.9298.782.75
243795-43795100.683101.78
344195-44195101.602102.71
441816-4181696.13397.16
541881-4188196.28397.33
641635-4163595.71796.77
15min141458-4145895.31097.092.5697.4199.242.57
243420-4342099.821102.03
343794-43794100.680102.92
441481-4148195.36397.46
541777-4177796.04398.16
641462-4146295.31997.43
20min140575-4057593.28095.622.7096.4498.842.70
242617-4261797.975101.30
343299-4329999.542102.90
440604-4060493.34796.50
541076-4107694.43297.62
641385-4138595.14298.31
30min140283-4028392.60993.472.3996.8097.752.40
241893-4189396.310100.72
341869-4186996.255100.72
439790-3979091.47595.67
540224-4022492.47396.71
639876-3987691.67395.90
45min139725-3972591.32692.852.4296.5598.182.43
241474-4147495.347100.83
341802-4180296.101101.63
439650-3965091.15496.36
539822-3982291.54996.81
639867-3986791.65296.90
极限139252-3925290.23992.442.5496.4798.792.55
241288-4128894.919101.46
341703-4170395.873102.47
439553-3955390.93197.15
539727-3972791.33197.61
639730-3973091.33797.60
培哚普利左氨氯地平项目信息
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%
19.604012340118401274017340174401430.07
29.584015640183401700.05
单位质量响应值RSD%判断
4181.564193.110.20数据可信
中间条件3月-供试品溶液-24050702批-培哚普利-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%
5min146497-4649795.81198.482.2795.8198.482.27
247067-4706796.98596.99
348891-48891100.744100.74
449306-49306101.599101.60
547474-4747497.82497.82
647510-4751097.89897.90
10min146534-4653495.88798.161.9696.9599.251.96
246706-4670696.24197.32
347950-4795098.80599.92
449078-49078101.129102.26
547883-4788398.66699.75
647668-4766898.22399.31
15min145661-4566194.08897.002.3896.2299.182.37
245961-4596194.70696.85
347901-4790198.704100.92
448568-48568100.078102.33
546973-4697396.79198.97
647378-4737897.62699.80
20min146064-4606494.91896.281.9298.0999.551.93
245629-4562994.02297.22
347193-4719397.245100.56
448183-4818399.285102.65
546542-4654295.90399.16
646752-4675296.33699.60
30min144848-4484892.41395.322.0696.6499.662.06
245995-4599594.77699.02
346984-4698496.814101.21
447560-4756098.001102.47
546401-4640195.61399.94
645776-4577694.32598.66
45min144364-4436491.41593.831.7496.6799.231.75
244930-4493092.58297.88
345566-4556693.89299.36
446610-4661096.043101.60
545904-4590494.58999.98
645853-4585394.48399.87
极限143816-4381690.28692.221.9896.5698.661.97
244188-4418891.05397.38
345611-4561193.985100.50
446078-4607894.947101.57
544433-4443391.55798.00
644415-4441591.52097.95
培哚普利左氨氯地平项目信息
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%
113.693816838132381133806538221381400.16
213.653758237680376310.19
单位质量响应值RSD%判断
2785.982756.850.75数据可信
中间条件3月-供试品溶液-24050702批-左氨氯地平-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%
5min139611-3961190.24495.283.1690.2495.283.16
241327-4132794.15394.15
342207-4220796.15896.16
443549-4354999.21699.22
542464-4246496.74496.74
641776-4177695.17695.18
10min140819-4081992.99694.982.2594.0096.042.26
240641-4064192.59093.64
341500-4150094.54795.62
443008-4300897.98399.09
542558-4255896.95898.03
641623-4162394.82895.89
15min140559-4055992.40494.362.0794.4496.482.08
240410-4041092.06494.14
341578-4157894.72596.84
442728-4272897.34599.54
541801-4180195.23397.39
641431-4143194.39096.50
20min141102-4110293.64193.931.8796.7097.091.87
240037-4003791.21494.31
341230-4123093.93297.10
442436-4243696.68099.95
541455-4145594.44597.66
641117-4111793.67596.83
30min140094-4009491.34493.041.9595.4597.251.95
240498-4049892.26596.38
340988-4098893.38197.60
442009-4200995.707100.05
541454-4145494.44398.70
639991-3999191.11095.31
45min139631-3963190.28991.651.5795.4196.891.57
239697-3969790.44095.58
339667-3966790.37195.62
440831-4083193.02398.43
540962-4096293.32298.63
640584-4058492.46197.67
极限139220-3922089.35390.311.5895.4796.571.59
239093-3909389.06495.21
339995-3999591.11997.38
440716-4071692.76199.21
539616-3961690.25596.60
639211-3921189.33295.57
培哚普利左氨氯地平项目信息
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%
19.604000540007400394012240126400600.16
29.583991739925399210.02
单位质量响应值RSD%判断
4172.924167.120.10数据可信
中间条件3月-供试品溶液-2024052721批-培哚普利-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%
5min147919-4791999.15198.861.0699.1598.861.06
247931-4793199.17599.18
347987-4798799.29199.29
446764-4676496.76196.76
548156-4815699.64199.64
647920-4792099.15399.15
10min147558-4755898.40498.741.2199.5199.841.20
247244-4724497.75498.86
348459-48459100.268101.37
446996-4699697.24198.32
548292-4829299.922101.03
647768-4776898.83899.94
15min147151-4715197.56198.190.7099.76100.380.71
247290-4729097.849100.04
347861-4786199.031101.25
447134-4713497.52699.68
547854-4785499.016101.23
647433-4743398.145100.34
20min146427-4642796.06396.450.7899.3499.740.77
246810-4681096.856100.13
347251-4725197.768101.09
446354-4635495.91299.15
546280-4628095.75999.08
646567-4656796.35399.64
30min146225-4622595.64595.531.5199.9999.891.47
245058-4505893.23197.58
346827-4682796.891101.30
445650-4565094.45698.76
546800-4680096.835101.22
646461-4646196.134100.49
45min145848-4584894.86594.460.54100.2799.880.55
245567-4556794.28499.67
345784-4578494.733100.21
445288-4528893.70799.06
545927-4592795.029100.49
645486-4548694.11699.55
极限145519-4551994.18593.580.87100.65100.050.82
245104-4510493.32699.76
344667-4466792.42298.95
444962-4496293.03299.43
545731-4573194.623101.14
645372-4537293.881100.36
培哚普利左氨氯地平项目信息
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%
113.693750937494375103754937556375240.08
213.653721437247372300.07
单位质量响应值RSD%判断
2740.982727.470.35数据可信
中间条件3月-供试品溶液-2024052721批-左氨氯地平-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%
5min141720-4172096.33997.901.2996.3497.901.29
242005-4200596.99797.00
342120-4212097.26397.26
442891-4289199.04399.04
542505-4250598.15298.15
643127-4312799.58899.59
10min141048-4104894.78797.172.2195.8698.262.20
241041-4104194.77195.85
341776-4177696.46997.55
443180-4318099.711100.81
542570-4257098.30299.39
642864-4286498.981100.09
15min140844-4084494.31697.102.1896.4499.262.17
241363-4136395.51597.65
341626-4162696.12298.27
443120-4312099.572101.78
542366-4236697.831100.01
642966-4296699.216101.42
20min140484-4048493.48595.712.1696.6698.962.14
241043-4104394.77697.97
341171-4117195.07198.29
442436-4243697.993101.31
540873-4087394.38397.65
642678-4267898.551101.86
30min140411-4041193.31794.702.0997.5399.012.07
239620-3962091.49095.74
341075-4107594.85099.13
441905-4190596.766101.17
541366-4136695.52299.84
641676-4167696.238100.64
45min140182-4018292.78894.051.4398.0399.421.46
240195-4019592.81898.08
340507-4050793.53898.87
441555-4155595.958101.44
540607-4060793.76999.15
641333-4133395.446100.92
极限140054-4005492.49293.421.9598.7799.831.93
239871-3987192.07098.36
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