富马酸比索洛尔左氨氯地平片项目信息
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对照品来源中检院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%
110.078391983946839208389883894839150.03
210.088379583814838040.02
单位质量响应值RSD%判断
8333.178313.890.17数据可信
长期3月-供试品溶液-2023101323批-富马酸比索洛尔-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%
5min191763-9176399.02298.091.5499.0298.081.54
290564-9056497.72997.73
393009-93009100.367100.37
491181-9118198.39498.39
589351-8935196.42096.42
689503-8950396.58496.58
10min192185-9218599.47898.851.3199.6499.011.31
291267-9126798.48798.65
393595-93595100.999101.17
491702-9170298.95799.12
590503-9050397.66397.82
690368-9036897.51797.68
15min191974-9197499.25098.421.4599.5898.741.45
290819-9081998.00498.33
393323-93323100.706101.04
491306-9130698.52998.86
589987-8998797.10697.43
689795-8979596.89997.22
20min191538-9153898.78098.011.3799.2898.501.38
290514-9051497.67598.17
392802-92802100.144100.65
490978-9097898.17598.67
589567-8956796.65397.14
689555-8955596.64097.12
30min191631-9163198.88097.711.4799.5498.371.47
290171-9017197.30597.96
392466-9246699.781100.45
490664-9066497.83798.49
589372-8937296.44297.09
688993-8899396.03396.68
45min187089-8708993.97996.501.8794.8097.321.87
289722-8972296.82097.64
392160-9216099.451100.29
489911-8991197.02497.84
588925-8892595.96096.77
688754-8875495.77596.58
极限190305-9030597.44996.411.4098.4397.391.40
288942-8894295.97896.96
391189-9118998.40399.41
489472-8947296.55097.53
587965-8796594.92495.89
688198-8819895.17596.14
富马酸比索洛尔左氨氯地平片项目信息
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705394253976539845399153977539740.04
214.695428254307542940.04
单位质量响应值RSD%判断
3671.703695.980.47数据可信
长期3月-供试品溶液-2023101323批-左氨氯地平-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%
5min154277-5427793.02786.308.5093.0386.308.50
245539-4553978.05178.05
353017-5301790.86890.87
444781-4478176.75276.75
554190-5419092.87892.88
650306-5030686.22186.22
10min150074-5007485.82490.502.7385.9890.642.72
252680-5268090.29090.42
352785-5278590.47090.62
453399-5339991.52291.65
553948-5394892.46392.62
653912-5391292.40292.55
15min152980-5298090.80490.203.1191.1090.493.11
251065-5106587.52287.80
352388-5238889.79090.09
450896-5089687.23287.51
553061-5306190.94391.25
655377-5537794.91395.21
20min148177-4817782.57285.595.8883.0286.045.84
249075-4907584.11184.54
353040-5304090.90791.36
451620-5162088.47388.90
545372-4537277.76578.23
652352-5235289.72890.18
30min152477-5247789.94287.781.5690.5388.371.55
250431-5043186.43587.00
350388-5038886.36286.97
451283-5128387.89688.47
551709-5170988.62689.22
651014-5101487.43588.04
45min148249-4824982.69688.104.3583.4388.834.31
251742-5174288.68289.39
353386-5338691.50092.25
452369-5236989.75790.48
553563-5356391.80392.54
649100-4910084.15484.91
极限155186-5518694.58588.544.2295.4689.424.16
251982-5198289.09489.95
350146-5014685.94786.85
453024-5302490.88091.75
549662-4966285.11786.01
649937-4993785.58986.48
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