培哚普利片项目信息
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%
19.844120541280411524119241173412000.12
29.874107541166411200.16
单位质量响应值RSD%判断
4186.994166.160.36数据可信
供试品溶液-736137批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19868-986820.38633.6629.9820.3933.6629.98
216869-1686934.85034.85
318057-1805737.30437.30
420675-2067542.71242.71
521403-2140344.21644.22
610887-1088722.49122.49
10min129253-2925360.43480.0921.9160.6680.4721.94
241631-4163186.00586.39
343929-4392990.75391.17
446029-4602995.09195.57
544993-4499392.95193.44
626779-2677955.32355.57
15min145275-4527593.53394.778.3794.4396.038.51
247843-4784398.838100.18
349012-49012101.253102.68
447570-4757098.27499.81
547083-4708397.26898.79
638446-3844679.42580.29
20min148857-48857100.93398.492.12102.87100.802.25
247361-4736197.843100.28
347962-4796299.084101.63
448141-4814199.454102.08
547848-4784898.849101.45
645869-4586994.76096.51
30min148288-4828899.75898.351.09102.82101.760.73
247309-4730997.735101.26
347481-4748198.091101.74
447432-4743297.989101.72
546964-4696497.023100.73
648171-4817199.516102.32
45min148332-4833299.84997.721.51104.02102.221.47
246560-4656096.188100.80
348014-4801499.192103.93
447187-4718797.483102.30
546922-4692296.936101.72
646786-4678696.655100.56
极限146778-4677896.63896.400.77101.91101.990.59
246323-4632395.698101.38
346928-4692896.948102.79
446675-4667596.425102.33
546176-4617695.395101.25
647102-4710297.308102.29
培哚普利片项目信息
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%
19.844122541225412344108641245412030.16
29.874111841317412180.35
单位质量响应值RSD%判断
4187.304176.090.19数据可信
供试品溶液-736137批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120420-2042042.13435.5314.7742.1335.5214.76
217637-1763736.39136.39
318381-1838137.92737.93
417119-1711935.32335.32
517056-1705635.19335.19
612692-1269226.18826.19
10min144012-4401290.81282.6410.5791.2883.0310.58
241164-4116484.93685.34
342350-4235087.38387.80
441293-4129385.20285.59
539525-3952581.55481.95
631960-3196065.94566.24
15min148302-4830299.66498.172.27101.1499.482.39
248249-4824999.555100.90
348555-48555100.186101.58
447401-4740197.80599.14
547337-4733797.67398.97
645627-4562794.14595.17
20min147396-4739697.79598.490.50100.38100.900.56
247924-4792498.884101.34
347985-4798599.010101.52
447823-4782398.676101.10
547779-4777998.585100.97
647498-4749898.005100.07
30min147727-4772798.47897.890.43102.15101.390.43
247342-4734297.683101.24
347409-4740997.822101.43
447290-4729097.576101.10
547223-4722397.438100.92
647652-4765298.323101.48
45min147303-4730397.60397.131.07102.37101.721.01
247792-4779298.612103.25
346476-4647695.896100.59
446871-4687196.711101.32
546627-4662796.208100.77
647379-4737997.760102.01
极限146976-4697696.92896.540.97102.78102.201.01
247257-4725797.508103.24
346859-4685996.687102.44
447109-4710997.203102.88
546040-4604094.997100.63
646482-4648295.909101.25
培哚普利片项目信息
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%
19.844125041185411484121941375412350.22
29.874118741278412320.16
单位质量响应值RSD%判断
4190.554177.510.23数据可信
供试品溶液-736137批-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%
5min117445-1744535.97536.412.9735.9836.412.96
217147-1714735.36135.36
317303-1730335.68235.68
418251-1825137.63737.64
517411-1741135.90535.91
618380-1838037.90337.90
10min142357-4235787.34985.792.5687.7586.202.56
240611-4061183.74884.14
340643-4064383.81484.21
441442-4144285.46285.88
541214-4121484.99285.39
643339-4333989.37489.80
15min149148-49148101.35399.412.07102.72100.772.05
247781-4778198.53499.86
347575-4757598.10999.44
449761-49761102.617103.99
547377-4737797.70199.04
647605-4760598.17199.59
20min148677-48677100.38298.492.11102.88100.952.10
246827-4682796.56798.99
347168-4716897.27099.69
449220-49220101.502104.01
546831-4683196.57599.00
647834-4783498.643101.15
30min147355-4735597.65698.041.58101.27101.591.57
247370-4737097.687101.18
347158-4715897.249100.75
448915-48915100.873104.51
546727-4672796.36199.86
647710-4771098.388101.99
45min148133-4813399.26097.912.20103.96102.562.18
246753-4675396.414100.99
346481-4648195.853100.43
449103-49103101.260106.02
546612-4661296.123100.70
647781-4778198.534103.23
极限147898-4789898.77596.902.46104.58102.642.42
245417-4541793.65999.31
346253-4625395.383101.03
448461-4846199.936105.82
546387-4638795.659101.30
647514-4751497.984103.77
培哚普利片项目信息
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%
19.844121041347413654132741466413430.23
29.874122141374412980.27
单位质量响应值RSD%判断
4201.524184.190.30数据可信
供试品溶液-736137批-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%
5min118358-1835837.77836.595.8537.7836.595.86
218829-1882938.74838.75
318017-1801737.07737.08
418432-1843237.93137.93
516130-1613033.19333.19
616908-1690834.79434.79
10min142740-4274087.95385.192.8488.3785.592.85
242530-4253087.52187.95
341859-4185986.14086.55
441028-4102884.43084.85
539831-3983181.96782.34
640387-4038783.11183.50
15min150050-50050102.996100.081.74104.39101.431.75
248943-48943100.718102.12
348665-48665100.146101.52
448505-4850599.817101.18
547992-4799298.761100.04
647628-4762898.01299.32
20min148577-4857799.96598.680.95102.51101.140.99
248168-4816899.123101.65
347877-4787798.524101.01
448188-4818899.164101.63
547589-4758997.932100.31
647314-4731497.36699.76
30min147762-4776298.28897.970.74101.94101.540.68
247637-4763798.030101.65
347083-4708396.890100.47
447307-4730797.351100.92
547975-4797598.726102.19
647892-4789298.555102.04
45min148503-4850399.81397.181.87104.56101.831.85
247868-4786898.506103.22
346825-4682596.360101.01
447457-4745797.660102.31
546190-4619095.05399.61
646498-4649895.687100.26
极限147279-4727997.29496.670.48103.15102.400.52
246932-4693296.580102.39
347074-4707496.872102.60
446984-4698496.687102.42
547000-4700096.720102.34
646593-4659395.882101.52
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