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%
110.354267242916433694313543023430230.61
210.294261342238424260.63
单位质量响应值RSD%判断
4156.814123.030.58数据可信
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%
5min149610-49610103.397102.691.22103.40102.691.22
248533-48533101.153101.15
350276-50276104.785104.79
449057-49057102.245102.24
549083-49083102.299102.30
649060-49060102.251102.25
10min149177-49177102.495102.020.96103.64103.160.96
248133-48133100.319101.44
349396-49396102.951104.12
449327-49327102.808103.94
548804-48804101.718102.85
648865-48865101.845102.98
15min148028-48028100.10098.522.91102.39100.792.86
245309-4530994.43396.67
348913-48913101.945104.25
448335-48335100.740103.02
546462-4646296.83699.10
646559-4655997.03899.31
20min146779-4677997.49798.461.51100.90101.831.49
247186-4718698.345101.63
348575-48575101.240104.68
447240-4724098.458101.86
546524-4652496.966100.31
647144-4714498.258101.60
30min147034-4703498.02897.730.77102.51102.190.76
246856-4685697.657102.04
347364-4736498.716103.28
446270-4627096.436100.93
546827-4682797.597102.02
646989-4698997.935102.37
45min147180-4718098.33397.161.27103.91102.711.25
246068-4606896.015101.48
347219-4721998.414104.08
446693-4669397.318102.88
546782-4678297.503103.01
645763-4576395.379100.91
极限145982-4598295.83694.081.83102.50100.711.77
244907-4490793.595100.13
346275-4627596.447103.20
444634-4463493.02699.67
544129-4412991.97498.56
644905-4490593.591100.18
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%
113.923862438583386283869638658386380.11
213.953789138666382781.44
单位质量响应值RSD%判断
2775.722743.940.82数据可信
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%
5min145093-45093103.165101.661.27103.16101.661.27
244565-44565101.957101.96
345087-45087103.151103.15
443970-43970100.596100.60
543841-43841100.300100.30
644061-44061100.804100.80
10min145167-45167103.334102.560.58104.48103.690.58
244544-44544101.909103.04
344921-44921102.771103.92
444586-44586102.005103.12
544693-44693102.250103.36
645059-45059103.087104.21
15min144271-44271101.28499.002.36103.58101.272.32
241884-4188495.82398.09
344324-44324101.406103.69
443870-43870100.367102.62
542550-4255097.34799.60
642736-4273697.772100.04
20min142001-4200196.09198.251.7199.51101.621.65
243446-4344699.397102.73
343966-43966100.586104.00
442675-4267597.633101.00
542354-4235496.898100.23
643219-4321998.877102.23
30min143023-4302398.42997.951.76102.92102.411.69
243789-43789100.182104.62
342990-4299098.354102.89
441494-4149494.93199.38
542614-4261497.493101.90
642970-4297098.308102.76
45min143001-4300198.37996.921.15103.96102.471.12
242586-4258697.429102.98
342688-4268897.663103.29
441731-4173195.473100.98
542277-4227796.722102.21
641898-4189895.855101.40
极限142147-4214796.42594.441.82103.10101.071.75
241676-4167695.347101.98
341929-4192995.926102.64
440817-4081793.38299.95
540237-4023792.05598.62
640869-4086993.501100.11
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%
110.354268842761425734277842741427080.20
210.294273742743427400.01
单位质量响应值RSD%判断
4126.384153.550.47数据可信
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%
5min146461-4646196.83399.672.6196.8399.672.61
248309-48309100.684100.68
349946-49946104.096104.10
447942-4794299.91999.92
547452-4745298.89898.90
646819-4681997.57997.58
10min145030-4503093.85097.612.3794.9398.722.35
247420-4742098.83199.95
346617-4661797.15898.31
447380-4738098.74899.86
546324-4632496.54797.65
648228-48228100.515101.60
15min144605-4460592.96496.033.3895.0898.223.34
244855-4485593.48695.70
348851-48851101.814104.05
446689-4668997.30899.52
546003-4600395.87898.05
645460-4546094.74696.95
20min144659-4465993.07795.363.0796.2398.622.99
244198-4419892.11695.37
346199-4619996.28799.65
446309-4630996.51699.80
548051-48051100.147103.38
645106-4510694.00997.26
30min144631-4463193.01994.662.7997.2098.972.72
243957-4395791.61495.89
346269-4626996.433100.87
445641-4564195.12499.48
547376-4737698.740103.09
644627-4462793.01097.31
45min143505-4350590.67293.904.4995.8999.274.33
244092-4409291.89597.19
348396-48396100.866106.37
443693-4369391.06496.48
546719-4671997.370102.82
643927-4392791.55196.88
极限143121-4312189.87291.773.0896.1098.192.99
242808-4280889.21995.54
344993-4499393.773100.40
442932-4293289.47895.91
546199-4619996.287102.82
644151-4415192.01898.37
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%
113.923855938636385613856338646385930.12
213.953860638600386030.02
单位质量响应值RSD%判断
2772.492767.240.14数据可信
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%
5min145723-45723104.224102.391.13104.22102.391.12
244862-44862102.261102.26
345331-45331103.330103.33
444545-44545101.539101.54
544487-44487101.407101.41
644571-44571101.598101.60
10min143890-43890100.04699.180.98101.20100.320.98
243480-4348099.111100.25
344119-44119100.568101.72
443066-4306698.16799.30
543091-4309198.22499.35
643422-4342298.979100.11
15min143128-4312898.30997.671.55100.5899.911.53
242558-4255897.00999.25
344064-44064100.442102.71
442262-4226296.33598.55
542540-4254096.96899.19
642535-4253596.95799.19
20min143077-4307798.19297.011.63101.55100.341.61
241870-4187095.44198.76
343705-4370599.624103.01
442113-4211395.99599.28
542333-4233396.49799.79
642257-4225796.32399.63
30min143116-4311698.28196.282.45102.73100.682.39
241709-4170995.07499.45
343933-43933100.144104.63
441577-4157794.77399.13
541571-4157194.76099.13
641515-4151594.63299.01
45min142014-4201495.76995.301.97101.31100.771.92
242119-4211996.009101.44
343174-4317498.414104.01
441487-4148794.56899.98
541116-4111693.72299.14
640930-4093093.29898.73
极限141759-4175995.18894.411.70101.80100.941.68
240838-4083893.08999.59
342628-4262897.169103.86
441203-4120393.921100.38
540708-4070892.79299.25
641362-4136294.283100.75
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%
110.354278942717427994271042818427670.12
210.294279142654427220.23
单位质量响应值RSD%判断
4132.084151.800.34数据可信
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%
5min146969-4696997.84497.810.6697.8497.810.66
246596-4659697.06797.07
346806-4680697.50597.50
446937-4693797.77897.78
546889-4688997.67897.68
647523-4752398.99899.00
10min146168-4616896.17697.011.5697.2698.101.54
247168-4716898.25999.34
347742-4774299.455100.54
446049-4604995.92897.01
545922-4592295.66396.75
646361-4636196.57897.68
15min145454-4545494.68894.490.7596.8496.650.74
244744-4474493.20995.38
345393-4539394.56196.75
445460-4546094.70196.85
545310-4531094.38896.54
645779-4577995.36597.54
20min145140-4514094.03493.960.6397.2497.170.62
244565-4456592.83696.04
345167-4516794.09097.33
445280-4528094.32697.53
545092-4509293.93497.13
645377-4537794.52897.76
30min144704-4470493.12693.230.7297.3897.490.70
244533-4453392.77097.01
345165-4516594.08698.37
444961-4496193.66197.91
544276-4427692.23496.48
644877-4487793.48697.77
45min144181-4418192.03692.491.0197.3297.780.98
243814-4381491.27296.54
344978-4497893.69799.03
444795-4479593.31598.61
544088-4408891.84397.11
644529-4452992.76198.08
极限143915-4391591.48291.350.8797.7997.680.84
243166-4316689.92296.20
344297-4429792.27898.65
443948-4394891.55197.88
543776-4377691.19397.48
644020-4402091.70198.05
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%
113.923862738590385603851538545385670.12
213.953871538658386860.11
单位质量响应值RSD%判断
2770.622773.190.07数据可信
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%
5min144927-44927102.334102.320.72102.33102.310.72
245366-45366103.334103.33
344890-44890102.250102.25
445186-45186102.924102.92
544593-44593101.573101.57
644551-44551101.478101.48
10min143761-4376199.67898.790.72100.8299.930.72
243472-4347299.020100.17
343487-4348799.054100.19
443514-4351499.115100.26
543049-4304998.05699.18
642946-4294697.82298.95
15min142828-4282897.55396.990.7799.8099.230.76
242353-4235396.47198.72
342819-4281997.53299.77
442951-4295197.833100.08
542148-4214896.00498.22
642397-4239796.57198.79
20min142715-4271597.29696.970.64100.62100.280.64
242529-4252996.872100.19
342733-4273397.337100.66
442923-4292397.769101.10
542315-4231596.38499.67
642213-4221396.15299.44
30min142294-4229496.33795.941.30100.75100.341.27
242304-4230496.359100.76
342662-4266297.175101.58
442582-4258296.993101.41
541431-4143194.37198.73
641456-4145694.42898.78
45min141919-4191995.48295.461.22100.96100.921.20
241832-4183295.284100.75
342627-4262797.095102.58
442350-4235096.464101.96
541323-4132394.12599.53
641413-4141394.33099.73
极限141408-4140894.31894.190.88100.86100.710.88
241368-4136894.227100.75
341863-4186395.355101.92
441572-4157294.692101.26
541071-4107193.551100.00
640833-4083393.00999.46
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