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%
110.128446284481844858447284626845050.09
210.178400983861839350.13
单位质量响应值RSD%判断
8350.308253.200.83数据可信
供试品溶液-25010303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%
5min191218-9121898.59797.741.1398.6097.741.13
290460-9046097.77897.78
388703-8870395.87995.88
490543-9054397.86797.87
591619-9161999.03099.03
690012-9001297.29397.29
10min191193-9119398.57098.001.1598.7398.161.14
291037-9103798.40198.56
388860-8886096.04896.21
490686-9068698.02298.19
591904-9190499.33899.50
690293-9029397.59797.76
15min191190-9119098.56797.731.1598.9098.061.15
290567-9056797.89398.22
388703-8870395.87996.20
490448-9044897.76598.09
591671-9167199.08799.42
689928-8992897.20397.53
20min190752-9075298.09397.381.1598.5997.871.15
290364-9036497.67498.16
388276-8827695.41795.90
490182-9018297.47797.97
591253-9125398.63599.13
689741-8974197.00197.49
30min190552-9055297.87797.041.1398.5397.691.13
289856-8985697.12597.78
388011-8801195.13195.77
489902-8990297.17597.83
590907-9090798.26198.92
689420-8942096.65497.30
45min189902-8990297.17596.541.1297.9997.361.12
289412-8941296.64597.46
387589-8758994.67495.47
489480-8948096.71897.53
590543-9054397.86798.69
688988-8898896.18797.00
极限189489-8948996.72895.991.0697.7196.961.06
288953-8895396.14997.12
387096-8709694.14295.10
488948-8894896.14397.12
589766-8976697.02898.01
688564-8856495.72896.70
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%
110.128376383642835588369483733836780.10
210.178369583653836740.04
单位质量响应值RSD%判断
8268.588227.530.36数据可信
供试品溶液-25010304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%
5min190011-9001197.92398.812.3797.9298.802.37
288655-8865596.44896.45
389511-8951197.37997.38
490021-9002197.93497.93
594474-94474102.778102.78
692262-92262100.372100.37
10min190429-9042998.37899.122.1798.5499.282.17
289011-8901196.83597.00
389910-8991097.81397.98
490566-9056698.52798.69
594522-94522102.830103.00
692219-92219100.325100.49
15min190236-9023698.16898.882.3298.4999.202.32
288824-8882496.63296.95
389396-8939697.25497.58
490242-9024298.17498.50
594551-94551102.862103.20
692076-92076100.169100.50
20min189962-8996297.87098.532.2198.3699.022.21
288574-8857496.36096.84
389185-8918597.02497.51
489879-8987997.77998.27
593981-93981102.242102.76
691807-9180799.877100.38
30min189644-8964497.52498.162.2698.1898.822.26
288134-8813495.88196.52
388891-8889196.70497.35
489553-8955397.42598.08
593723-93723101.961102.65
691455-9145599.494100.16
45min189183-8918397.02297.662.2797.8498.482.27
287682-8768295.38996.19
388441-8844196.21597.03
489063-8906396.89297.71
593262-93262101.460102.31
690987-9098798.98599.82
极限188728-8872896.52797.072.2697.5198.062.26
287205-8720594.87095.83
387932-8793295.66196.63
488412-8841296.18397.16
592720-92720100.870101.89
690377-9037798.32199.32
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%
110.128373883716838108377583822837720.06
210.178380683987838960.16
单位质量响应值RSD%判断
8277.878249.360.25数据可信
供试品溶液-25010305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%
5min190615-9061598.39497.802.3598.3997.802.35
292261-92261100.181100.18
392082-9208299.98799.99
490259-9025998.00898.01
588226-8822695.80095.80
686947-8694794.41194.41
10min191682-9168299.55398.872.2399.7299.042.24
293079-93079101.070101.24
393008-93008100.993101.16
491224-9122499.05599.22
589359-8935997.03097.19
687989-8798995.54395.70
15min191478-9147899.33198.692.1999.6699.022.19
292981-92981100.963101.30
392696-92696100.654100.99
491046-9104698.86299.19
589274-8927496.93897.26
687868-8786895.41195.73
20min191092-9109298.91298.372.2999.4198.862.29
292748-92748100.710101.21
392579-92579100.527101.03
490711-9071198.49898.99
589004-8900496.64597.13
687417-8741794.92295.40
30min190705-9070598.49297.992.2699.1598.642.26
292311-92311100.236100.91
392186-92186100.100100.77
490428-9042898.19198.85
588721-8872196.33896.98
687079-8707994.55595.19
45min190225-9022597.97197.702.2898.8098.522.28
292123-92123100.032100.87
391836-9183699.720100.56
490481-9048198.24999.07
588339-8833995.92396.73
686824-8682494.27895.07
极限189891-8989197.60897.122.2398.6098.102.23
291432-9143299.281100.29
391395-9139599.241100.24
489668-8966897.36698.35
587870-8787095.41396.38
686399-8639993.81694.76
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