富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.118476584381848518369183596842570.70
210.138462984789847090.14
单位质量响应值RSD%判断
8334.038362.190.24数据可信
供试品溶液-2025120521批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197128-97128104.503103.141.02104.50103.141.02
295036-95036102.253102.25
397066-97066104.437104.44
495197-95197102.426102.43
595437-95437102.684102.68
695279-95279102.514102.51
10min196064-96064103.359102.361.30103.53102.541.30
293995-93995101.133101.30
396885-96885104.242104.42
495230-95230102.461102.63
593612-93612100.720100.89
695055-95055102.273102.44
15min195628-95628102.890101.931.33103.24102.271.33
294016-94016101.155101.49
396364-96364103.681104.03
494507-94507101.683102.02
592794-9279499.840100.18
695096-95096102.317102.66
20min195379-95379102.622101.281.66103.14101.791.66
291847-9184798.82199.33
396039-96039103.332103.85
494176-94176101.327101.84
592876-9287699.929100.43
694486-94486101.661102.17
30min194665-94665101.853101.261.16102.54101.941.16
293368-93368100.458101.13
395816-95816103.092103.78
493945-93945101.079101.76
592649-9264999.684100.36
694213-94213101.367102.05
45min194703-94703101.894100.531.45102.75101.381.44
292409-9240999.426100.27
395339-95339102.579103.44
493093-93093100.162101.01
591797-9179798.76899.61
693278-93278100.361101.21
极限193886-93886101.015100.141.33102.04101.161.33
292160-9216099.158100.16
394774-94774101.971103.01
493086-93086100.155101.17
591293-9129398.22599.23
693239-93239100.319101.34
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.118375884424842208433084341842150.32
210.138440284595844980.17
单位质量响应值RSD%判断
8329.878341.360.10数据可信
供试品溶液-2025120522批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194709-94709102.053101.271.40102.05101.271.40
292266-9226699.42199.42
394626-94626101.964101.96
494265-94265101.575101.57
592492-9249299.66499.66
695551-95551102.961102.96
10min192876-92876100.078100.820.91100.25100.990.91
293335-93335100.573100.74
394636-94636101.975102.14
493929-93929101.213101.38
592404-9240499.56999.74
694216-94216101.522101.69
15min192365-9236599.527100.411.0299.86100.741.03
292918-92918100.123100.46
394380-94380101.699102.04
493703-93703100.969101.31
591896-9189699.02299.35
693823-93823101.099101.44
20min192231-9223199.383100.201.0799.89100.701.07
292537-9253799.713100.21
393962-93962101.248101.76
493546-93546100.800101.31
591648-9164898.75599.25
694002-94002101.291101.80
30min192029-9202999.165100.201.6899.83100.871.67
292249-9224999.402100.07
393869-93869101.148101.83
493054-93054100.270100.94
591173-9117398.24398.90
695545-95545102.954103.63
45min191072-9107298.13499.121.0598.9799.961.05
291802-9180298.92199.75
393140-93140100.363101.21
492547-9254799.724100.56
590702-9070297.73698.56
692679-9267999.866100.72
极限190867-9086797.91398.750.9498.9199.750.93
292178-9217899.326100.32
392387-9238799.551100.57
491768-9176898.88499.89
590333-9033397.33898.33
692320-9232099.479100.50
富马酸比索洛尔片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.118395883945839568393484436840460.26
210.138369283922838070.20
单位质量响应值RSD%判断
8313.168273.150.35数据可信
供试品溶液-G02PSP批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152879-5287957.27262.1718.0157.2762.1718.01
268553-6855374.24874.25
364771-6477170.15170.15
453195-5319557.61457.61
540907-4090744.30544.31
664123-6412369.45069.45
10min173003-7300379.06782.8711.4779.1682.9811.47
286123-8612393.27793.40
379002-7900285.56585.68
476777-7677783.15583.25
561268-6126866.35766.43
682935-8293589.82489.94
15min183578-8357890.52193.007.6690.7593.247.67
291846-9184699.47699.75
387289-8728994.54094.80
488411-8841195.75595.99
573745-7374579.87180.06
690307-9030797.80998.07
20min189575-8957597.01697.774.7197.3998.174.73
292271-9227199.936100.38
389257-8925796.67197.09
494292-94292102.125102.52
582674-8267489.54289.86
693560-93560101.332101.76
30min193495-93495101.26199.582.94101.80100.142.96
291976-9197699.616100.23
390198-9019897.69198.27
494963-94963102.851103.42
587531-8753194.80295.27
693502-93502101.269101.87
45min194815-94815102.69199.952.73103.40100.682.74
292162-9216299.818100.60
389840-8984097.30398.04
494966-94966102.855103.59
588899-8889996.28496.91
693037-93037100.765101.53
极限194037-94037101.84999.172.68102.73100.062.69
290993-9099398.55299.50
389331-8933196.75297.65
493894-93894101.694102.60
588199-8819995.52696.31
692927-92927100.646101.58
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