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%
110.288434384329842198451084513843830.16
210.278435784429843930.07
单位质量响应值RSD%判断
8208.468217.430.08数据可信
供试品溶液-24112101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%
5min193864-93864102.55198.856.37102.5598.856.37
287839-8783995.96895.97
380502-8050287.95287.95
497067-97067106.050106.05
592451-92451101.007101.01
691135-9113599.56999.57
10min193971-93971102.667102.332.29102.84102.502.30
291557-91557100.030100.19
390878-9087899.28899.43
496728-96728105.680105.86
594363-94363103.096103.26
694501-94501103.246103.41
15min193896-93896102.585102.741.88102.93103.071.89
291754-91754100.245100.57
392413-92413100.965101.28
496613-96613105.554105.91
594631-94631103.389103.73
694895-94895103.677104.01
20min193397-93397102.040102.401.86102.55102.901.86
291485-9148599.951100.45
392228-92228100.763101.24
496269-96269105.178105.71
594245-94245102.967103.48
694707-94707103.472103.98
30min193166-93166101.788102.001.80102.47102.671.81
291160-9116099.596100.26
391909-91909100.415101.06
495834-95834104.703105.41
593843-93843102.528103.21
694228-94228102.948103.63
45min192600-92600101.170101.381.87102.02102.231.88
290460-9046098.83299.66
391319-9131999.770100.59
495266-95266104.082104.96
593372-93372102.013102.87
693744-93744102.419103.27
极限192254-92254100.792101.611.24101.81102.631.24
293579-93579102.239103.23
391325-9132599.777100.76
494667-94667103.428104.48
592906-92906101.504102.53
693289-93289101.922102.95
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%
110.288456184441845138430584499844640.12
210.278453984499845190.04
单位质量响应值RSD%判断
8216.348229.700.12数据可信
供试品溶液-24112102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%
5min188111-8811196.14796.191.3096.1596.191.30
288937-8893797.04997.05
389392-8939297.54597.55
487805-8780595.81395.81
588532-8853296.60796.61
686131-8613193.98793.99
10min188206-8820696.25196.421.2496.4196.581.24
289170-8917097.30397.46
389495-8949597.65797.82
488054-8805496.08596.24
588819-8881996.92097.08
686446-8644694.33094.49
15min188341-8834196.39896.341.2296.7296.661.22
288612-8861296.69497.02
389640-8964097.81698.14
487901-8790195.91896.24
588793-8879396.89197.21
686432-8643294.31594.63
20min187949-8794995.97095.981.1896.4596.461.18
288427-8842796.49296.98
389189-8918997.32497.81
487513-8751395.49595.97
588474-8847496.54397.03
686189-8618994.05094.52
30min187652-8765295.64695.661.2696.2996.301.26
288195-8819596.23996.88
389000-8900097.11797.77
487386-8738695.35695.99
588042-8804296.07296.72
685722-8572293.54094.17
45min187012-8701294.94895.091.1595.7595.881.15
287760-8776095.76496.57
388215-8821596.26197.07
486790-8679094.70695.50
587655-8765595.65096.45
685399-8539993.18893.97
极限186855-8685594.77794.681.2995.7495.641.29
287298-8729895.26096.23
387994-8799496.02096.99
486350-8635094.22695.18
587297-8729795.25996.22
684779-8477992.51193.45
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%
110.288440984398846318452084538844990.12
210.278457284512845420.06
单位质量响应值RSD%判断
8219.758231.940.11数据可信
供试品溶液-24112103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%
5min186604-8660494.47094.444.3494.4794.444.34
283277-8327790.84190.84
390328-9032898.53398.53
481033-8103388.39388.39
588145-8814596.15196.15
690063-9006398.24498.24
10min188803-8880396.86999.802.1697.0399.962.16
289713-8971397.86298.01
393924-93924102.455102.62
492764-92764101.190101.34
592645-92645101.060101.22
691088-9108899.36299.53
15min188417-8841796.448100.032.5696.77100.352.56
289919-8991998.08698.40
394232-94232102.791103.13
494117-94117102.666102.98
592565-92565100.973101.30
690936-9093699.19699.53
20min188275-8827596.29399.742.6296.77100.232.62
289430-8943097.55398.03
393903-93903102.432102.94
494054-94054102.597103.08
592403-92403100.796101.29
690552-9055298.77799.27
30min188343-8834396.36799.682.5897.01100.342.58
289380-8938097.49898.14
393877-93877102.404103.08
493954-93954102.488103.15
592272-92272100.653101.32
690473-9047398.69199.35
45min187637-8763795.59799.122.7096.4099.952.70
288803-8880396.86997.67
393498-93498101.991102.84
493542-93542102.039102.87
591672-9167299.999100.83
690065-9006598.24699.07
极限187086-8708694.99698.542.6595.9699.532.64
288421-8842196.45297.42
392851-92851101.285102.30
492836-92836101.268102.27
591337-9133799.633100.63
689505-8950597.63598.62
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%
110.288449684606844108423084334844150.18
210.278468984578846340.10
单位质量响应值RSD%判断
8211.588240.900.26数据可信
供试品溶液批-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%
5min169600-6960075.91880.285.8675.9280.285.86
271361-7136177.83977.84
370002-7000276.35776.36
475146-7514681.96881.97
574376-7437681.12881.13
681083-8108388.44488.44
10min184936-8493692.64793.792.6392.7793.922.63
282940-8294090.46990.60
385864-8586493.65993.79
488041-8804196.03496.17
584994-8499492.71092.85
689116-8911697.20697.35
15min188690-8869096.74196.851.4597.0297.141.45
288010-8801096.00096.28
388695-8869596.74797.03
490336-9033698.53798.83
586929-8692994.82195.11
690099-9009998.27898.59
20min188481-8848196.51396.931.4096.9697.381.40
289451-8945197.57298.01
388662-8866296.71197.16
490278-9027898.47498.93
586704-8670494.57595.02
689589-8958997.72298.20
30min188519-8851996.55597.031.4897.1697.651.48
289941-8994198.10698.71
388583-8858396.62597.23
490339-9033998.54099.17
586738-8673894.61295.22
689618-8961897.75498.39
45min188279-8827996.29396.581.4597.0697.361.44
289411-8941197.52898.29
388232-8823296.24297.01
489907-8990798.06998.86
586302-8630294.13794.90
689132-8913297.22498.02
极限187703-8770395.66596.031.3696.5996.971.36
288983-8898397.06197.99
387694-8769495.65596.58
489125-8912597.21698.17
585971-8597193.77694.70
688777-8877796.83697.80
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