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%
110.124477344089443324438644738444640.66
29.944283742791428140.08
单位质量响应值RSD%判断
4393.684307.241.41数据可信
加速6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%
5min149295-4929597.77797.571.9997.7897.561.99
249863-4986398.90398.90
348799-4879996.79396.79
450463-50463100.094100.09
549114-4911497.41897.42
647596-4759694.40794.41
10min150409-5040999.98698.271.42101.0799.361.41
250248-5024899.667100.77
349081-4908197.35298.43
449622-4962298.42599.54
548574-4857496.34797.43
649334-4933497.85498.90
15min149028-4902897.24797.511.5699.4499.691.55
249688-4968898.556100.76
348110-4811095.42697.58
450076-5007699.326101.53
548456-4845696.11398.27
649612-4961298.406100.54
20min147051-4705193.32692.331.8896.6095.591.86
247464-4746494.14597.45
345944-4594491.13094.35
447369-4736993.95797.27
545317-4531789.88693.11
646151-4615191.54194.77
30min146329-4632991.89490.681.2296.2194.971.22
246107-4610791.45395.80
345461-4546190.17294.40
446121-4612191.48195.83
544881-4488189.02293.24
645417-4541790.08594.33
45min146022-4602291.28590.111.7596.6295.401.73
246014-4601491.26996.63
344467-4446788.20093.43
446352-4635291.93997.31
544736-4473688.73493.94
644980-4498089.21894.47
极限144854-4485488.96889.261.0895.3295.551.07
245660-4566090.56796.94
344692-4469288.64794.86
445384-4538490.01996.41
545086-4508689.42895.62
644321-4432187.91194.15
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%
114.013882839077390263860138414387890.73
214.073837738274383260.20
单位质量响应值RSD%判断
2768.672723.951.16数据可信
加速6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%
5min141254-4125494.85095.433.0794.8595.433.07
241942-4194296.43296.43
340427-4042792.94892.95
443787-43787100.674100.67
540305-4030592.66892.67
641314-4131494.98894.99
10min143855-43855100.83098.931.66101.8899.991.67
242533-4253397.79098.86
342527-4252797.77798.81
443987-43987101.133102.25
542377-4237797.43298.46
642890-4289098.61199.67
15min143919-43919100.97799.471.36103.15101.631.36
243250-4325099.439101.60
342479-4247997.66699.79
443679-43679100.425102.67
542645-4264598.048100.16
643607-43607100.260102.41
20min142310-4231097.27895.892.94100.5799.162.89
243028-4302898.928102.19
341021-4102194.31497.52
442985-4298598.830102.19
540221-4022192.47595.68
640675-4067593.51996.78
30min141128-4112894.56093.801.6198.9498.121.60
241848-4184896.215100.58
340585-4058593.31297.56
440909-4090994.05798.51
540008-4000891.98596.21
640296-4029692.64796.95
45min140984-4098494.22993.012.5499.6698.382.50
241320-4132095.001100.43
339734-3973491.35596.64
441743-4174395.974101.48
539236-3923690.21095.46
639711-3971191.30296.64
极限139968-3996891.89392.262.7498.3798.672.63
241287-4128794.926101.41
339972-3997291.90298.21
441149-4114994.608101.18
540160-4016092.33498.59
638240-3824087.92094.27
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%
110.124275742816428174276742724427760.10
29.944285042850428500.00
单位质量响应值RSD%判断
4226.884310.871.40数据可信
长期6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%
5min148645-4864598.33198.670.8098.3398.670.79
249537-49537100.135100.13
348893-4889398.83398.83
448559-4855998.15898.16
548783-4878398.61098.61
648464-4846497.96697.97
10min148638-4863898.31798.841.1399.4199.941.12
249639-49639100.341101.45
349511-49511100.082101.18
448773-4877398.59099.68
548565-4856598.17099.27
648268-4826897.56998.66
15min148963-4896398.97498.180.61101.16100.380.61
248679-4867998.400100.63
348798-4879898.641100.85
448360-4836097.75599.94
548455-4845597.947100.13
648168-4816897.36799.54
20min148286-4828697.60696.801.41100.89100.081.38
248376-4837697.788101.11
348050-4805097.129100.43
448395-4839597.826101.10
547526-4752696.06999.34
646685-4668594.36997.62
30min146724-4672494.44894.620.7498.8298.980.74
247182-4718295.37499.78
346747-4674794.49598.88
447177-4717795.36499.72
546765-4676594.53198.87
646254-4625493.49897.80
45min146664-4666494.32793.801.5099.7599.221.46
246720-4672094.44099.91
347201-4720195.413100.85
446481-4648193.95799.38
546199-4619993.38798.78
645158-4515891.28396.62
极限146068-4606893.12293.130.8199.5999.590.81
246363-4636393.719100.24
346213-4621393.41599.91
446370-4637093.733100.20
546065-4606593.11699.55
645365-4536591.70198.06
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%
114.013820138235382843814038225382170.14
214.073825538273382640.04
单位质量响应值RSD%判断
2727.842719.550.22数据可信
长期6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%
5min140410-4041093.67594.311.7793.6794.311.77
240849-4084994.69294.69
340599-4059994.11394.11
439524-3952491.62191.62
541684-4168496.62896.63
641042-4104295.14095.14
10min142082-4208297.551101.002.1798.59102.052.15
243979-43979101.948103.00
344822-44822103.902104.95
443222-43222100.193101.21
543245-43245100.247101.32
644082-44082102.187103.24
15min143226-43226100.203100.881.17102.33103.051.17
243448-43448100.717102.90
344201-44201102.463104.66
442979-4297999.630101.76
543176-43176100.087102.27
644086-44086102.196104.39
20min142610-4261098.77599.200.83102.01102.490.82
242883-4288399.407102.71
343298-43298100.369103.71
442888-4288899.419102.66
542229-4222997.891101.19
642853-4285399.338102.67
30min140816-4081694.61696.991.4598.95101.381.42
241914-4191497.161101.57
342509-4250998.540102.99
441982-4198297.319101.66
541521-4152196.250100.64
642290-4229098.033102.46
45min141029-4102995.11096.701.78100.50102.171.73
241540-4154096.294101.78
343030-4303099.748105.30
441952-4195297.249102.67
541036-4103695.126100.58
641699-4169996.663102.18
极限140599-4059994.11395.671.16100.56102.221.15
241321-4132195.787102.34
341779-4177996.848103.51
441399-4139995.967102.47
540811-4081194.604101.12
641722-4172296.716103.31
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%
110.124279042721426724272042705427220.11
29.944272142743427320.04
单位质量响应值RSD%判断
4221.544298.991.29数据可信
中间条件6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%
5min147309-4730995.82396.471.5495.8296.471.54
246561-4656194.30894.31
347201-4720195.60495.60
448254-4825497.73797.74
547969-4796997.15997.16
648490-4849098.21598.21
10min147600-4760096.41296.991.8997.4898.061.88
246618-4661894.42395.47
347162-4716295.52596.59
448861-4886198.966100.05
548716-4871698.67299.75
648354-4835497.93999.03
15min147236-4723695.67595.921.6997.8198.071.68
246198-4619893.57295.67
347008-4700895.21397.34
448213-4821397.65499.84
548322-4832297.874100.05
647173-4717395.54797.73
20min146538-4653894.26195.582.4197.4698.792.37
245647-4564792.45695.59
346602-4660294.39197.57
447684-4768496.58299.85
547862-4786296.943100.21
648794-4879498.830102.07
30min145469-4546992.09695.844.7096.34100.114.56
245816-4581692.79996.96
346160-4616093.49597.73
447646-4764696.505100.85
547290-4729095.784100.12
651513-51513104.338108.68
45min145457-4545792.07192.871.7997.3498.211.79
244668-4466890.47395.67
345482-4548292.12297.39
447000-4700095.197100.61
546367-4636793.91599.32
646134-4613493.44398.94
极限145890-4589092.94892.731.4099.2499.101.42
244819-4481990.77996.98
345220-4522091.59197.88
446318-4631893.815100.29
546447-4644794.077100.52
646006-4600693.18399.72
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%
114.013815638261381323812738124381600.16
214.073826838292382800.05
单位质量响应值RSD%判断
2723.772720.680.09数据可信
中间条件6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%
5min141517-4151796.29398.251.9196.2998.251.91
242200-4220097.87797.88
343317-43317100.467100.47
442776-4277699.21399.21
541357-4135795.92195.92
643005-4300599.74499.74
10min141994-4199497.39998.521.0098.4799.621.00
242037-4203797.49998.59
342965-4296599.651100.77
442893-4289399.484100.59
542335-4233598.19099.26
642643-4264398.904100.01
15min141551-4155196.37197.331.5398.5299.511.51
241344-4134495.89198.06
343003-4300399.739101.96
442329-4232998.176100.38
542096-4209697.63599.79
641456-4145696.15198.36
20min141048-4104895.20596.801.5398.43100.071.52
241041-4104195.18998.42
342479-4247998.524101.86
441816-4181696.986100.28
541601-4160196.48799.73
642442-4244298.438101.71
30min140271-4027193.40396.202.0197.68100.541.97
241060-4106095.23399.53
342048-4204897.524101.95
441824-4182497.005101.38
541070-4107095.25699.57
642582-4258298.763103.13
45min140075-4007592.94894.151.5298.2799.561.51
240149-4014993.12098.47
341488-4148896.225101.74
441203-4120395.564101.02
540080-4008092.96098.33
640561-4056194.07599.54
极限139907-3990792.55893.891.0698.91100.351.08
240239-4023993.32899.72
341177-4117795.504102.08
440675-4067594.340100.86
540405-4040593.713100.12
640494-4049493.920100.43
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