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2402201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.7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%
110.078469384655847068434084778846340.21
210.118461084571845900.04
单位质量响应值RSD%判断
8404.578366.960.32数据可信
供试品溶液-24102901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%
5min189351-8935195.60991.785.1195.6191.785.11
280730-8073086.38486.38
387414-8741493.53693.54
488571-8857194.77494.77
579664-7966485.24385.24
688913-8891395.14095.14
10min191506-9150697.91496.461.3398.0796.611.33
291469-9146997.87598.02
388965-8896595.19595.35
489549-8954995.82095.98
588846-8884695.06895.21
690522-9052296.86297.02
15min191078-9107897.45696.281.1797.7896.591.17
291220-9122097.60897.92
388637-8863794.84595.16
489170-8917095.41595.73
589497-8949795.76596.07
690263-9026396.58496.90
20min190933-9093397.30196.051.2597.7996.521.24
291141-9114197.52497.99
388429-8842994.62295.09
488791-8879195.00995.49
589339-8933995.59696.06
689923-8992396.22196.70
30min190435-9043596.76895.641.1197.4296.271.11
290452-9045296.78797.42
388094-8809494.26394.89
488499-8849994.69795.33
589097-8909795.33795.96
689696-8969695.97896.62
45min189791-8979196.07995.071.0696.8995.871.05
289919-8991996.21697.01
387725-8772593.86994.66
487880-8788094.03494.83
588652-8865294.86195.64
689141-8914195.38496.19
极限189520-8952095.78994.581.2496.7695.531.24
289627-8962795.90496.86
386912-8691292.99993.94
487417-8741793.53994.49
588370-8837094.55995.50
688491-8849194.68895.65
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2402201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.7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%
110.078460284530844838455384529845390.06
210.118448784614845500.11
单位质量响应值RSD%判断
8395.138363.010.28数据可信
供试品溶液-24102901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%
5min190687-9068797.11596.001.1497.1296.001.14
289699-8969996.05796.06
389084-8908495.39995.40
490290-9029096.69096.69
587911-8791194.14394.14
690204-9020496.59896.60
10min191658-9165898.15597.041.0398.3297.201.03
290519-9051996.93697.10
389881-8988196.25296.41
491302-9130297.77497.94
589223-8922395.54895.70
691129-9112997.58997.75
15min191309-9130997.78296.800.9598.1197.120.95
290345-9034596.74997.07
389763-8976396.12696.45
491056-9105697.51197.83
589065-8906595.37995.69
690808-9080897.24597.57
20min191142-9114297.60396.541.0998.0997.021.09
289930-8993096.30596.79
389413-8941395.75196.23
491038-9103897.49197.98
588698-8869894.98595.46
690688-9068897.11797.60
30min190536-9053696.95496.051.0397.6096.701.03
289651-8965196.00696.65
388983-8898395.29195.93
490558-9055896.97797.63
588261-8826194.51895.15
690166-9016696.55897.21
45min190064-9006496.44882.8736.8197.2683.6836.45
289189-8918995.51196.31
388481-8848194.75395.55
419276-1927620.64221.45
587694-8769493.91094.70
689628-8962895.98196.79
极限189598-8959895.94994.961.0896.9295.911.06
288685-8868594.97295.93
387941-8794194.17595.13
489554-8955495.90296.75
587192-8719293.37394.32
689101-8910195.41796.39
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2402201对照品来源原料对照品使用方法直接使用
对照品含量(%)99.7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%
110.078434784345844768445984280843810.10
210.118445784359844080.09
单位质量响应值RSD%判断
8379.448348.960.26数据可信
供试品溶液-24102901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%
5min154766-5476658.75266.1824.0958.7566.1824.09
273336-7333678.67478.67
350822-5082254.52154.52
459002-5900263.29763.30
546652-4665250.04850.05
685539-8553991.76591.77
10min175610-7561081.11482.3410.7581.2182.4510.77
282330-8233088.32388.45
376174-7617481.71981.81
473449-7344978.79578.90
564294-6429468.97469.06
688645-8864595.09795.25
15min181133-8113387.03988.596.0487.2788.846.07
285341-8534191.55391.83
383982-8398290.09590.32
480106-8010685.93786.17
575173-7517380.64580.84
689764-8976496.29896.61
20min183833-8383389.93591.443.8390.3191.843.87
286610-8661092.91493.35
386488-8648892.78393.16
482756-8275688.78089.16
581345-8134587.26687.60
690390-9039096.96997.44
30min185496-8549691.71994.342.6892.2594.892.69
287549-8754993.92294.51
389120-8912095.60796.14
484999-8499991.18691.71
589562-8956296.08196.56
690930-9093097.54998.18
45min186115-8611592.38395.212.7193.0695.912.70
287768-8776894.15794.90
389831-8983196.37097.06
486171-8617192.44393.12
591451-9145198.10898.75
691143-9114397.77798.57
极限186318-8631892.60195.262.7693.4496.132.76
287716-8771694.10195.00
389527-8952796.04496.90
486156-8615692.42793.26
591374-9137498.02598.83
691715-9171598.39199.35
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