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%
19.713929939395393293932639358393410.10
29.743945839671395640.39
单位质量响应值RSD%判断
4051.604062.010.19数据可信
长期12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%
5min146427-4642798.74497.311.4798.7497.311.47
246243-4624398.35398.35
345978-4597897.78997.79
445860-4586097.53897.54
545435-4543596.63596.63
644576-4457694.80894.81
10min146156-4615698.16897.621.3099.2798.701.30
246666-4666699.253100.35
345640-4564097.07198.16
446388-4638898.66199.75
545351-4535196.45697.53
645182-4518296.09697.15
15min145598-4559896.98196.641.4899.1798.801.47
246306-4630698.487100.68
345514-4551496.80398.97
445725-4572597.25199.43
545185-4518596.10398.25
644296-4429694.21296.33
20min144869-4486995.43195.162.3998.7098.402.34
246271-4627198.413101.70
344766-4476695.21298.45
445290-4529096.32699.59
543108-4310891.68594.90
644150-4415093.90297.07
30min145094-4509495.90995.341.75100.2499.641.74
245981-4598197.796102.18
344846-4484695.38299.68
445136-4513695.999100.33
544076-4407693.74497.98
643824-4382493.20897.42
45min144826-4482695.33994.101.74100.7399.461.72
245428-4542896.620102.09
343832-4383293.22598.58
444124-4412493.84699.24
543993-4399393.56898.84
643269-4326992.02897.27
极限143897-4389793.36392.961.6399.8199.361.60
245015-4501595.741102.28
343091-4309191.64998.04
443658-4365892.85599.30
543144-4314491.76298.08
643432-4343292.37498.64
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%
113.413762037785378213769637721377290.21
213.433806337850379560.40
单位质量响应值RSD%判断
2813.502826.210.32数据可信
长期12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%
5min142186-4218694.45792.341.9894.4692.341.98
240595-4059590.89590.89
341275-4127592.41792.42
441866-4186693.74193.74
541515-4151592.95592.95
639998-3999889.55889.56
10min142193-4219394.47392.881.6295.5293.901.62
241278-4127892.42493.43
340867-4086791.50492.53
442370-4237094.86995.91
541421-4142192.74493.78
640752-4075291.24692.24
15min141682-4168293.32991.791.4995.4393.851.49
240954-4095491.69993.74
340756-4075691.25593.30
441512-4151292.94895.04
541100-4110092.02594.09
639974-3997489.50491.51
20min140569-4056990.83790.051.7693.9793.131.73
240608-4060890.92493.98
340189-4018989.98693.04
441130-4113092.09395.22
539202-3920287.77690.86
639620-3962088.71291.72
30min140906-4090691.59190.081.7695.7494.151.74
240507-4050790.69894.76
339649-3964988.77792.83
440911-4091191.60295.75
540243-4024390.10794.17
639158-3915887.67791.67
45min140359-4035990.36688.871.6795.5393.951.66
239807-3980789.13094.20
338956-3895687.22592.27
440255-4025590.13395.30
539965-3996589.48494.55
638800-3880086.87691.84
极限139489-3948988.41888.201.3594.5994.261.34
239685-3968588.85794.92
338653-3865386.54692.56
440202-4020290.01596.19
539127-3912787.60893.66
639188-3918887.74493.67
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%
19.713893339071388943895238980389660.18
29.743978039904398420.23
单位质量响应值RSD%判断
4012.984090.551.36数据可信
中间条件12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%
5min145630-4563097.17997.850.6397.1897.850.62
246326-4632698.66198.66
345932-4593297.82297.82
445807-4580797.55697.56
546251-4625198.50198.50
645723-4572397.37797.38
10min145654-4565497.23098.331.1198.3199.421.09
245706-4570697.34198.44
345903-4590397.76098.85
446859-4685999.796100.88
546681-4668199.417100.51
646219-4621998.43399.52
15min144751-4475195.30796.561.4597.4798.741.43
245224-4522496.31498.49
344933-4493395.69497.87
445345-4534596.57298.76
546597-4659799.238101.44
645179-4517996.21898.39
20min144203-4420394.14095.881.7397.3699.131.70
245303-4530396.48299.73
345015-4501595.86999.11
445609-4560997.134100.40
545978-4597897.920101.22
644012-4401293.73396.98
30min143792-4379293.26494.941.0797.5399.261.06
244337-4433794.42598.74
344507-4450794.78799.09
444996-4499695.828100.17
545061-4506195.967100.36
644773-4477395.35499.64
45min143086-4308691.76194.251.7197.0699.621.67
244595-4459594.974100.34
343978-4397893.66099.02
444512-4451294.798100.21
545337-4533796.555102.01
644028-4402893.76799.11
极限143315-4331592.24893.321.1898.5799.741.16
243789-4378993.25899.68
344017-4401793.744100.14
443955-4395593.611100.07
544615-4461595.017101.55
643207-4320792.01898.41
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%
113.413752437308375403732937273373950.34
213.433811838012380650.20
单位质量响应值RSD%判断
2788.592834.331.16数据可信
中间条件12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%
5min142080-4208094.50793.841.4094.5193.841.40
242353-4235395.12095.12
341348-4134892.86392.86
440908-4090891.87591.87
541676-4167693.60093.60
642338-4233895.08695.09
10min142575-4257595.61993.771.4496.6794.821.42
241043-4104392.17893.23
341069-4106992.23693.27
441806-4180693.89294.91
542029-4202994.39295.43
642001-4200194.32995.39
15min141459-4145993.11292.531.4295.2294.611.40
241198-4119892.52694.61
340354-4035490.63092.69
440989-4098992.05794.12
542123-4212394.60396.69
641070-4107092.23994.34
20min140808-4080891.65091.121.2194.8094.241.18
240856-4085691.75894.87
340259-4025990.41793.48
440460-4046090.86993.96
541209-4120992.55195.69
639841-3984189.47892.61
30min140860-4086091.76790.341.1095.9394.471.08
239841-3984189.47893.61
339811-3981189.41193.48
439968-3996889.76493.86
540225-4022590.34194.51
640649-4064991.29395.42
45min139832-3983289.45889.741.1294.6494.871.09
240229-4022990.35095.47
339562-3956288.85293.91
439444-3944488.58793.68
540649-4064991.29396.47
640025-4002589.89295.03
极限139960-3996089.74689.120.7095.9295.250.70
239568-3956888.86594.99
339689-3968989.13795.19
439332-3933288.33594.41
540053-4005389.95496.14
639496-3949688.70494.84
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