培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.763975539852396933974139696397470.17
29.693980839607397080.36
单位质量响应值RSD%判断
4072.444097.830.44数据可信
长期24月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211479774800147989100.2398.381.4296.91%～99.84%
246661462694646597.05
346832467744680397.75
446783466874673597.61
5480134781447914100.07
646884465174670097.54
2024030221147395476334751499.2498.021.2696.73%～99.32%
245796462494602296.12
347491473754743399.07
446482464684647597.07
546692470614687697.90
647298472484727398.73
2024030321145467453774542294.8797.251.9095.32%～99.18%
246421463214637196.85
346391462604632696.75
446136462084617296.43
547111470594708598.34
6480564794348000100.25
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.041648691647971648631645171644291646950.13
214.041648491651191649840.12
单位质量响应值RSD%判断
11730.4111751.000.13数据可信
长期24月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117571317589017580297.0796.071.4094.66%～97.47%
217426317414217420296.18
317311717302917307395.56
417110317166017138294.63
517759717774117766998.10
617182917176917179994.86
2024030221117629317571717600597.1896.001.5494.45%～97.54%
217044317032317038394.08
317748517719817734297.92
417156117231917194094.93
517249817256417253195.26
617505717486017495896.60
2024030321116953716921116937493.5295.521.5593.97%～97.07%
217394417408917401696.08
317179117152017165694.78
417105917141817123894.55
517558017541217549696.90
617617617622417620097.29
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.763976539777398053972739635397420.17
29.693959239659396260.12
单位质量响应值RSD%判断
4071.934089.370.31数据可信
长期24月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211478344787447854100.0699.181.2497.89%～100.47%
2478394807247956100.27
3479774791647946100.25
447360473564735899.02
546559465734656697.36
647042468204693198.13
20240302211478124807747944100.24100.291.1799.07%～101.51%
246963470034698398.23
3484424823348338101.07
4480794793948009100.38
5478784792247900100.15
6486064865048628101.67
2024030321146393467734658397.4098.981.5597.38%～100.58%
247178472414721098.71
3486854877848732101.89
447164472824722398.74
547370471944728298.86
646909470854699798.26
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.048235982535824778249682462824660.08
214.048230581803820540.44
单位质量响应值RSD%判断
5873.655844.300.36数据可信
长期24月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121188777885168864698.0897.821.5796.21%～99.42%
290207901149016099.76
388933887618884798.30
488634883398848697.90
586151856738591295.06
688428883738840097.81
2024030221189860896298974499.3097.941.4496.46%～99.42%
286185862338620995.38
389766893968958199.12
488565881588836297.77
588694888578877698.22
688318885748844697.86
2024030321185758859758586695.0096.011.1094.91%～97.12%
286168861398615495.32
388405878998815297.53
487575874988753696.85
585974858208589795.04
687343868098707696.34
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.763948439849396593963839766396790.35
29.693964239591396160.10
单位质量响应值RSD%判断
4065.474088.340.40数据可信
长期24月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121147470471814732699.0499.191.3997.75%～100.63%
246652464774656497.45
347507474094745899.32
447373472314730298.99
5485834856648574101.65
647047472494714898.67
20240302211478804795447917100.2899.340.6998.62%～100.05%
247044473254718498.75
347079473164719898.78
447083472874718598.75
547423476604754299.49
647726477984776299.96
2024030321145933458524589296.0498.831.9796.79%～100.87%
246761466344669897.73
346806470614693498.22
447322475484743599.27
5477864787547830100.10
6486024850648554101.61
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.041647431647261651981649811649021649100.12
214.041645501646941646220.07
单位质量响应值RSD%判断
11745.7311725.210.13数据可信
长期24月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117495017486417490796.6296.811.2995.51%～98.12%
217420917353717387396.05
317525717521817523896.80
417359117328117343695.80
517968017962017965099.24
617449917443117446596.37
2024030221117725717746617736297.9796.820.9395.88%～97.75%
217331817317817324895.70
317538517491917515296.75
417387417389017388296.05
517493217519417506396.70
617690217692417691397.72
2024030321117018916973416996293.8896.411.7394.66%～98.15%
217462717486617474696.53
317349617355117352495.85
417354917315517335295.76
517733317731517732497.95
617845017812317828698.48
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.763970339834397623980539655397520.19
29.693974439843397940.18
单位质量响应值RSD%判断
4072.954106.710.59数据可信
长期24月-供试品溶液-培哚普利-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211482254808848156100.4699.660.9098.73%～100.59%
2480054798247994100.12
3482644821148238100.63
447151471424714698.36
547526474754750099.09
647634475504759299.29
20240302211488484890248875101.96101.311.19100.05%～102.57%
2479414801847980100.10
3485944874848671101.54
4480684796748018100.17
5483154836148338100.84
6495174947049494103.25
2024030321146956468464690197.8499.581.5597.96%～101.20%
247307472704728898.65
3489274882048874101.96
4483014839848350100.87
547646476044762599.35
647292474184735598.79
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.048241182642826888265082302825390.21
214.048248482095822900.34
单位质量响应值RSD%判断
5878.855861.110.22数据可信
长期24月-供试品溶液-氨氯地平-pH2.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189163889218904298.3397.921.1696.72%～99.11%
289789900358991299.29
388771886188869497.95
487424877448758496.72
587124875058731496.43
689314895788944698.78
20240302211910849120191142100.6598.621.4597.12%～100.12%
287304873028730396.41
389984902509011799.52
488776887388875798.02
589294892318926298.58
689188892738923098.54
2024030321185797858278581294.7796.271.4394.83%～97.71%
286739867608675095.80
388136876498789297.06
488995893678918198.49
586177860748612695.11
687475870728727496.38
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