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%
110.068309583185832708321983240832020.09
210.008310383094830980.01
单位质量响应值RSD%判断
8270.588309.800.34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%
5min134233-3423337.05361.6128.6437.0561.6128.65
245384-4538449.12249.12
373393-7339379.43879.44
467176-6717672.70972.71
548927-4892752.95752.96
672434-7243478.40078.40
10min150472-5047254.62977.2217.8354.6977.3217.85
262465-6246567.61067.69
381601-8160188.32288.45
481318-8131888.01688.14
571378-7137877.25777.35
680819-8081987.47687.61
15min164232-6423269.52385.5510.6969.6885.7810.72
273467-7346779.51879.71
384857-8485791.84792.13
484226-8422691.16491.43
582780-8278089.59989.82
684673-8467391.64891.92
20min175240-7524081.43889.985.9681.7190.366.00
278672-7867285.15285.48
386814-8681493.96594.40
485226-8522692.24692.67
585861-8586192.93393.30
686996-8699694.16294.59
30min186833-8683393.98594.931.7094.3995.451.75
285514-8551492.55893.03
388983-8898396.31396.90
486964-8696494.12794.70
588635-8863595.93696.46
689285-8928596.63997.23
45min191282-9128298.80196.731.5699.3697.411.52
288361-8836195.63996.26
389966-8996697.37698.13
487289-8728994.47995.21
589447-8944796.81597.50
689854-8985497.25598.00
极限191823-9182399.38696.831.74100.1197.671.68
289114-8911496.45497.24
389944-8994497.35398.26
486996-8699694.16295.05
589250-8925096.60297.44
689615-8961596.99797.91
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%
110.068329083287832478324883049832240.13
210.008330883329833180.02
单位质量响应值RSD%判断
8272.768331.800.51数据可信
供试品溶液-24103001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%
5min126996-2699629.17759.3332.7829.1859.3332.78
267135-6713572.56072.56
353544-5354457.87057.87
464242-6424269.43369.43
575641-7564181.75381.75
641816-4181645.19545.19
10min140350-4035043.61076.3824.0743.6676.4824.08
282298-8229888.94889.07
374363-7436380.37280.47
480672-8067287.19087.31
584690-8469091.53391.67
661630-6163066.61066.69
15min151057-5105755.18284.0818.5955.3084.3018.62
287519-8751994.59194.86
381447-8144788.02888.26
487266-8726694.31794.58
587660-8766094.74395.03
671809-7180977.61177.80
20min159533-5953364.34388.4214.2264.5688.7914.25
289142-8914296.34596.77
384362-8436291.17991.56
488932-8893296.11896.54
589671-8967196.91697.36
679223-7922385.62485.94
30min172883-7288378.77293.708.1179.0994.228.18
290455-9045597.76498.35
387410-8741094.47395.00
491070-9107098.42999.01
591410-9141098.79699.40
686967-8696793.99494.45
45min185371-8537192.26997.152.7792.7297.822.87
290936-9093698.28499.03
389155-8915596.35997.05
491949-9194999.379100.12
592025-9202599.461100.23
689883-8988397.14697.76
极限190581-9058197.90098.191.1298.5199.021.16
291378-9137898.76199.68
388957-8895796.14596.99
491562-9156298.96099.87
591672-9167299.079100.02
690956-9095698.30599.08
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%
110.068323083265831328309583040831520.12
210.008336083148832540.19
单位质量响应值RSD%判断
8265.618325.400.51数据可信
供试品溶液-24110801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%
5min119027-1902720.58145.9540.1020.5845.9540.10
239349-3934942.56342.56
355977-5597760.54960.55
429994-2999432.44432.44
565884-6588471.26671.27
644652-4465248.29948.30
10min140506-4050643.81571.9224.3143.8572.0024.32
263169-6316968.32968.40
373675-7367579.69379.79
461990-6199067.05467.11
589625-8962596.94697.06
669961-6996175.67675.76
15min158235-5823562.99284.6214.4863.1084.8114.51
276642-7664282.90283.09
382105-8210588.81289.05
478060-7806084.43684.60
592829-92829100.412100.69
681488-8148888.14488.35
20min171596-7159677.44492.548.7877.6692.888.83
285292-8529292.25992.58
388309-8830995.52295.90
485903-8590392.92093.23
594073-94073101.757102.21
688130-8813095.32995.68
30min185749-8574992.75399.533.4593.09100.023.52
292779-92779100.358100.83
394038-94038101.719102.26
492189-9218999.719100.18
594329-94329102.034102.65
693015-93015100.613101.13
45min192420-9242099.969102.151.27100.47102.811.32
295572-95572103.379104.02
395517-95517103.319104.03
494006-94006101.685102.31
594116-94116101.804102.59
695000-95000102.760103.44
极限192911-92911100.500101.931.02101.16102.761.06
295154-95154102.927103.74
395358-95358103.147104.03
493719-93719101.374102.17
593652-93652101.302102.26
694591-94591102.318103.17
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