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%
19.734065140568406914097940637407050.40
29.694071541098409060.67
单位质量响应值RSD%判断
4183.454221.470.64数据可信
影响因素30天-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%
5min146950-4695096.39896.392.0396.4096.392.03
248136-4813698.83398.83
346706-4670695.89795.90
447687-4768797.91197.91
545375-4537593.16493.16
646813-4681396.11696.12
10min146306-4630695.07597.191.5196.1598.261.49
247225-4722596.96298.06
347725-4772597.98999.05
448100-4810098.75999.85
547931-4793198.41299.45
646726-4672695.93897.01
15min145331-4533193.07396.261.9195.2098.411.87
246898-4689896.29198.47
347503-4750397.53399.69
446522-4652295.51997.70
547168-4716896.84598.97
647874-4787498.295100.43
20min145501-4550193.42394.732.3996.5897.952.31
245700-4570093.83197.08
346734-4673495.95499.19
445201-4520192.80796.05
548116-4811698.792102.00
645565-4556593.55496.78
30min145303-4530393.01693.792.9497.2298.062.83
246372-4637295.21199.50
346380-4638095.22799.53
446435-4643595.34099.62
546481-4648195.43599.74
643096-4309688.48592.75
45min143408-4340889.12592.972.3994.3698.292.31
245926-4592694.29599.64
346112-4611294.677100.04
445121-4512192.64297.98
546276-4627695.014100.38
644844-4484492.07497.32
极限144527-4452791.42392.841.5697.6599.191.53
245550-4555093.52399.92
345701-4570193.833100.25
444751-4475191.88398.25
546216-4621694.891101.31
644562-4456291.49597.77
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%
113.513728837283371013707837116371730.28
213.473760137871377360.51
单位质量响应值RSD%判断
2751.522801.481.28数据可信
影响因素30天-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%
5min133914-3391477.12775.638.6677.1375.638.66
234995-3499579.58579.59
332266-3226673.37973.38
436121-3612182.14682.15
527987-2798763.64863.65
634244-3424477.87877.88
10min136379-3637982.73386.252.7583.5987.102.72
237662-3766285.65186.54
337924-3792486.24787.06
439480-3948089.78590.70
538564-3856487.70288.41
637554-3755485.40586.27
15min136136-3613682.18086.722.9783.9688.522.94
238495-3849587.54589.38
338134-3813486.72488.50
438359-3835987.23689.15
538042-3804286.51588.20
639624-3962490.11391.93
20min137080-3708084.32786.342.6387.0289.102.49
237985-3798586.38589.19
338181-3818186.83189.57
436893-3689383.90286.78
539690-3969090.26392.91
637966-3796686.34289.16
30min136684-3668483.42787.113.1987.0590.833.08
238347-3834787.20990.98
339066-3906688.84492.55
439285-3928589.34293.15
539495-3949589.81993.47
636938-3693884.00487.78
45min135896-3589681.63587.103.3686.1991.793.23
238640-3864087.87592.61
338455-3845587.45492.14
438138-3813886.73391.54
539616-3961690.09594.74
639045-3904588.79693.50
极限137933-3793386.26789.542.2091.7395.202.15
240434-4043491.95597.67
339206-3920689.16294.82
439357-3935789.50695.27
540076-4007691.14196.79
639227-3922789.21094.90
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%
19.734076140815407984109540886408710.33
29.694129240846410690.77
单位质量响应值RSD%判断
4200.514238.290.64数据可信
影响因素30天-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%
5min146951-4695196.01396.861.0896.0196.861.09
247105-4710596.32796.33
347323-4732396.77396.77
447833-4783397.81697.82
546859-4685995.82495.82
648131-4813198.42698.43
10min146211-4621194.49996.631.3895.5797.701.38
247652-4765297.44698.52
347775-4777597.69898.77
447362-4736296.85397.94
546710-4671095.52096.58
647798-4779897.74598.84
15min146366-4636694.81695.671.3396.9397.811.32
246354-4635494.79296.94
347060-4706096.23598.40
446789-4678995.68197.84
546242-4624294.56396.69
647876-4787697.904100.08
20min145336-4533692.71094.851.3395.8898.071.32
246764-4676495.63098.84
346814-4681495.73298.96
446330-4633094.74397.97
546070-4607094.21197.39
646988-4698896.08899.36
30min143088-4308888.11391.201.7692.3195.471.72
245204-4520492.44096.71
344489-4448990.97895.27
445149-4514992.32896.61
544775-4477591.56395.79
644887-4488791.79296.13
45min144270-4427090.53091.030.7495.7196.310.74
244420-4442090.83796.13
344436-4443690.87096.17
444331-4433190.65595.96
544472-4447290.94396.18
645162-4516292.35497.71
极限144927-4492791.87491.710.8698.0698.000.83
245062-4506292.15098.45
344303-4430390.59896.91
444711-4471191.43297.74
544646-4464691.29997.55
645426-4542692.89499.28
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%
113.513748537450371033694037456372870.67
213.473722837397373120.33
单位质量响应值RSD%判断
2759.962770.010.26数据可信
影响因素30天-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%
5min135686-3568681.48982.041.5381.4982.041.53
236270-3627082.82282.82
336013-3601382.23582.24
436564-3656483.49483.49
534978-3497879.87279.87
636061-3606182.34582.35
10min137870-3787086.47687.471.0087.3888.380.98
238400-3840087.68688.61
338921-3892188.87689.79
438042-3804286.86987.80
538493-3849387.89988.79
638112-3811287.02987.94
15min138083-3808386.96287.731.4688.8389.621.42
237952-3795286.66388.56
338586-3858688.11190.01
437930-3793086.61388.51
538581-3858188.09989.96
639387-3938789.94091.82
20min137324-3732485.22987.941.7788.0690.801.73
238823-3882388.65291.51
339379-3937989.92292.80
438674-3867488.31291.17
538336-3833687.54090.38
638541-3854188.00890.89
30min134016-3401677.67583.214.2181.4587.044.04
237614-3761485.89189.73
335134-3513480.22884.11
437919-3791986.58890.42
536905-3690584.27288.09
637055-3705584.61588.47
45min137209-3720984.96785.291.0289.6190.050.97
237038-3703884.57689.37
337459-3745985.53790.31
436867-3686784.18688.98
537821-3782186.36491.12
637721-3772186.13690.93
极限138521-3852187.96288.131.0393.5593.840.98
238193-3819387.21392.95
338563-3856388.05893.78
438197-3819787.22392.96
538892-3889288.81094.52
639206-3920689.52795.28
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%
19.734084040838408084072440845408110.13
29.694055140523405370.05
单位质量响应值RSD%判断
4194.354183.380.19数据可信
影响因素30天-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%
5min149079-49079101.09499.181.40101.0999.181.39
247197-4719797.21797.22
348304-4830499.49899.50
448632-48632100.173100.17
547718-4771898.29198.29
647970-4797098.81098.81
10min148648-48648100.20698.611.07101.3399.711.07
247096-4709697.00998.09
347901-4790198.66799.77
447969-4796998.80899.92
547999-4799998.86999.96
647621-4762198.09199.19
15min148272-4827299.43297.421.78101.6799.621.77
246243-4624395.25297.41
347619-4761998.087100.29
447376-4737697.58699.80
547950-4795098.768100.96
646325-4632595.42197.61
20min147752-4775298.36195.801.34101.7099.081.33
246302-4630295.37498.59
346406-4640695.58898.88
446259-4625995.28598.58
546288-4628895.34598.63
646044-4604494.84298.09
30min146960-4696096.72995.211.18101.1699.551.17
245951-4595194.65198.93
345929-4592994.60698.96
446804-4680496.408100.76
546115-4611594.98999.34
645564-4556493.85498.16
45min146649-4664996.08994.291.54101.6099.701.52
244845-4484592.37397.70
345997-4599794.746100.15
446116-4611694.991100.42
546050-4605094.855100.26
645006-4500692.70498.05
极限145840-4584094.42293.330.68101.0099.780.71
245068-4506892.83299.19
345276-4527693.26099.72
445459-4545993.637100.12
545198-4519893.10099.56
645011-4501192.71599.09
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%
113.513684936891368053722737218369980.57
213.473697637042370090.13
单位质量响应值RSD%判断
2738.562747.510.24数据可信
影响因素30天-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%
5min136864-3686484.85283.641.9384.8583.641.93
236521-3652184.06384.06
336390-3639083.76183.76
436888-3688884.90784.91
534986-3498680.52980.53
636369-3636983.71383.71
10min138744-3874489.17988.642.1490.1289.572.12
237868-3786887.16388.10
338475-3847588.56089.49
439526-3952690.97991.92
539146-3914690.10591.00
637292-3729285.83786.77
15min139047-3904789.87789.121.9291.8191.041.90
238057-3805787.59889.50
338750-3875089.19391.11
439557-3955791.05193.00
539278-3927890.40892.30
637628-3762886.61188.49
20min137941-3794187.33187.751.4390.2690.651.41
238388-3838888.36091.24
337608-3760886.56589.47
438802-3880289.31392.28
538544-3854488.71991.62
637443-3744386.18589.03
30min137679-3767986.72887.982.0790.6391.862.03
238210-3821087.95091.81
337558-3755886.44990.32
439671-3967191.31395.27
538478-3847888.56792.45
637745-3774586.88090.68
45min138205-3820587.93988.331.5992.8193.181.55
237900-3790087.23792.07
338385-3838588.35393.18
438631-3863188.91993.89
539414-3941490.72295.59
637704-3770486.78691.55
极限139054-3905489.89389.411.0395.7495.251.04
239113-3911390.02995.83
338536-3853688.70194.51
439290-3929090.43696.40
538847-3884789.41695.29
638222-3822287.97893.71
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%
19.734074140616405274070440494406160.27
29.694088540834408600.09
单位质量响应值RSD%判断
4174.314216.720.72数据可信
影响因素30天-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%
5min147393-4739397.46998.321.1097.4798.321.10
248376-4837699.49099.49
347852-4785298.41398.41
448469-4846999.68299.68
547197-4719797.06697.07
647546-4754697.78397.78
10min147397-4739797.47797.251.5198.5698.341.50
246761-4676196.16997.27
347248-4724897.17198.26
448516-4851699.778100.89
546438-4643895.50596.58
647362-4736297.40598.49
15min146217-4621795.05095.911.3097.2298.081.27
247725-4772598.152100.33
346879-4687996.41298.58
446223-4622395.06397.28
546169-4616994.95197.09
646600-4660095.83898.01
20min144782-4478292.09994.071.7295.3297.311.69
246783-4678396.21499.48
345875-4587594.34797.59
446471-4647195.57398.85
545067-4506792.68595.88
645463-4546393.50096.73
30min144576-4457691.67592.631.0695.9296.911.06
245341-4534193.24997.58
344873-4487392.28696.58
445816-4581694.22698.56
544591-4459191.70695.93
645044-4504492.63896.91
45min144971-4497192.48892.381.4497.7597.691.40
245325-4532593.21698.59
345121-4512192.79698.11
445687-4568793.96099.34
544543-4454391.60796.85
643854-4385490.19095.49
极限144680-4468091.88991.021.6098.1897.361.53
245109-4510992.77199.18
344171-4417190.84297.19
444528-4452891.57798.00
544007-4400790.50596.77
643054-4305488.54594.85
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%
113.513676337112371053690937060369900.41
213.473712237375372480.49
单位质量响应值RSD%判断
2737.972765.260.71数据可信
影响因素30天-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%
5min127818-2781863.83265.802.0863.8365.802.08
229306-2930667.24767.25
328831-2883166.15766.16
428846-2884666.19166.19
529167-2916766.92866.93
628086-2808664.44764.45
10min137854-3785486.86186.971.5687.5787.701.55
237651-3765186.39587.14
338448-3844888.22488.96
436897-3689784.66585.40
538481-3848188.30089.04
638067-3806787.35088.07
15min137776-3777686.68287.512.4988.3689.212.46
238637-3863788.65890.36
338824-3882489.08790.80
436490-3649083.73185.41
539094-3909489.70691.43
638000-3800087.19688.88
20min138405-3840588.12587.651.1390.7690.321.13
238342-3834287.98190.67
338713-3871388.83291.54
437583-3758386.23988.85
538367-3836788.03890.76
637768-3776886.66489.32
30min138632-3863288.64687.331.9492.2690.971.89
237372-3737285.75589.42
338982-3898289.44993.14
437225-3722585.41888.98
538489-3848988.31892.02
637650-3765086.39390.01
45min138312-3831287.91287.522.2792.5192.132.17
236446-3644683.63088.25
338445-3844588.21792.90
438146-3814687.53192.05
538804-3880489.04193.72
638685-3868588.76893.35
极限139328-3932890.24388.592.5895.8294.182.45
238908-3890889.28094.83
338639-3863988.66294.33
438362-3836288.02793.51
539604-3960490.87796.55
636801-3680184.44590.01
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%
19.734072840559406974074540678406810.19
29.694088741076409820.33
单位质量响应值RSD%判断
4180.994229.310.82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%
5min147979-4797998.44996.401.1598.4596.401.15
246943-4694396.32396.32
346426-4642695.26295.26
446617-4661795.65495.65
546968-4696896.37496.37
646962-4696296.36296.36
10min146789-4678996.00795.071.4297.1096.141.41
246706-4670695.83796.91
345392-4539293.14094.20
446043-4604394.47695.54
547142-4714296.73197.80
645913-4591394.20995.28
15min145802-4580293.98294.801.5396.1496.931.50
246105-4610594.60396.74
345662-4566293.69495.79
445605-4560593.57795.69
547421-4742197.30499.45
646617-4661795.65497.77
20min146733-4673395.89294.901.3499.1098.081.33
246053-4605394.49797.68
345104-4510492.54995.68
446333-4633395.07198.22
546521-4652195.45798.68
646745-4674595.91799.10
30min146703-4670395.83093.651.67100.1097.881.64
244911-4491192.15396.39
344952-4495292.23796.40
445192-4519292.73096.94
546381-4638195.17099.46
645696-4569693.76498.01
45min144724-4472491.77092.120.8397.1097.400.82
244632-4463291.58196.84
344433-4443391.17396.36
445239-4523992.82698.07
545392-4539293.14098.49
644943-4494392.21997.51
极限144963-4496392.26092.010.7798.6198.300.78
244660-4466091.63897.92
344594-4459491.50397.70
444704-4470491.72998.00
545488-4548893.33799.72
644625-4462591.56697.88
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%
113.513691636746370213661537258369110.68
213.473688836776368320.22
单位质量响应值RSD%判断
2732.122734.370.06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%
5min134063-3406378.68581.482.7978.6981.492.79
236721-3672184.82584.83
334471-3447179.62879.63
435769-3576982.62682.63
534880-3488080.57380.57
635744-3574482.56982.57
10min136310-3631083.87685.993.8284.7586.893.79
239020-3902090.13691.08
335747-3574782.57583.46
437065-3706585.62086.54
538929-3892989.92690.82
636276-3627683.79784.71
15min136701-3670184.77987.132.9886.5988.992.96
238987-3898790.06092.00
337173-3717385.87087.67
437475-3747586.56788.44
539237-3923790.63792.53
636731-3673184.84986.70
20min136041-3604183.25587.343.2686.0090.173.24
239172-3917290.48793.43
336614-3661484.57887.33
437969-3796987.70890.54
538761-3876189.53892.44
638306-3830688.48791.28
30min136410-3641084.10788.293.1587.7892.093.12
239244-3924490.65494.60
338048-3804887.89191.59
437523-3752386.67890.48
539761-3976191.84895.74
638348-3834888.58492.36
45min134775-3477580.33086.764.3784.9491.544.27
238468-3846888.86193.82
336662-3666284.68989.36
437707-3770787.10391.87
539402-3940291.01995.94
638344-3834488.57593.33
极限137532-3753286.69989.451.8392.2095.201.90
239441-3944191.10997.05
338377-3837788.65194.26
438893-3889389.84395.58
539375-3937590.95696.88
638730-3873089.46695.21
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