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100711-202203对照品来源中检所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%
19.858459884583847218438584632845840.15
29.818506985064850660.01
单位质量响应值RSD%判断
8587.218671.360.69数据可信
供试品溶液-25053001批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193325-9332597.14297.770.7497.1497.770.74
294798-9479898.67598.68
394801-9480198.67898.68
493406-9340697.22697.23
593605-9360597.43397.43
693612-9361297.44197.44
10min194616-9461698.48698.400.6398.6598.570.62
295157-9515799.04999.21
395069-9506998.95799.12
493531-9353197.35697.52
594501-9450198.36698.53
694345-9434598.20498.37
15min194315-9431598.17298.170.7698.5098.500.76
295193-9519399.08699.42
394812-9481298.69099.02
493096-9309696.90497.23
594161-9416198.01298.34
694294-9429498.15198.48
20min194221-9422198.07598.040.6198.5698.530.61
294793-9479398.67099.16
394590-9459098.45998.95
493145-9314596.95597.44
594153-9415398.00498.49
694214-9421498.06798.56
30min194105-9410597.95497.870.6798.6198.520.68
294595-9459598.46499.12
394541-9454198.40899.07
492850-9285096.64797.29
593999-9399997.84398.50
694055-9405597.90298.55
45min193876-9387697.71597.520.7298.5398.340.72
294324-9432498.18299.01
394200-9420098.05398.87
492453-9245396.23497.04
593694-9369497.52698.34
693582-9358297.40998.23
极限193503-9350397.32797.320.7398.3198.300.73
294175-9417598.02799.01
394183-9418398.03599.02
492330-9233096.10697.08
593387-9338797.20698.19
693417-9341797.23898.22
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100711-202203对照品来源中检所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%
19.858416784110843688419084347842360.14
29.818474285026848840.24
单位质量响应值RSD%判断
8551.888652.800.83数据可信
供试品溶液-25053002批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min192606-9260696.69696.931.5296.7096.931.52
293940-9394098.08998.09
393456-9345697.58497.58
494513-9451398.68898.69
591533-9153395.57695.58
690910-9091094.92694.93
10min192936-9293697.04197.831.6197.2097.991.61
294681-9468198.86399.03
394677-9467798.85999.02
495600-9560099.82399.99
591759-9175995.81295.97
692504-9250496.59096.75
15min193081-9308197.19297.721.5397.5298.051.53
294603-9460398.78299.11
394297-9429798.46298.79
495441-9544199.65799.99
591747-9174795.79996.12
692350-9235096.42996.75
20min192835-9283596.93697.531.6197.4298.021.61
294001-9400198.15398.65
394287-9428798.45298.94
495580-9558099.802100.30
591534-9153495.57796.06
692181-9218196.25396.73
30min192508-9250896.59497.251.5397.2497.901.53
293957-9395798.10798.76
393934-9393498.08398.74
495102-9510299.30399.97
591379-9137995.41596.05
691938-9193895.99996.64
45min192444-9244496.52797.211.5797.3398.021.57
293576-9357697.70998.53
393913-9391398.06198.88
495301-9530199.510100.34
591255-9125595.28696.08
692093-9209396.16196.96
极限192382-9238296.46396.871.4597.4397.841.45
293411-9341197.53798.52
393422-9342297.54898.53
494673-9467398.85599.85
590895-9089594.91095.87
691849-9184995.90696.87
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100711-202203对照品来源中检所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%
19.858434584935848518453684697846730.29
29.818446284251843560.18
单位质量响应值RSD%判断
8596.248598.980.03数据可信
供试品溶液-25053003批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min195753-95753100.03496.792.48100.0396.792.47
292252-9225296.37696.38
394495-9449598.72098.72
489113-8911393.09793.10
592098-9209896.21696.22
692191-9219196.31396.31
10min197088-97088101.42998.372.29101.6098.532.29
293509-9350997.69097.85
395365-9536599.62999.79
490621-9062194.67394.83
593954-9395498.15598.31
694432-9443298.65498.81
15min196669-96669100.99198.142.24101.3398.462.24
293350-9335097.52497.85
395416-9541699.682100.01
490487-9048794.53394.85
593630-9363097.81698.14
694073-9407398.27998.60
20min196408-96408100.71897.922.31101.2298.402.31
293050-9305097.21097.70
395084-9508499.33599.83
490035-9003594.06094.53
593593-9359397.77798.26
694194-9419498.40598.89
30min196200-96200100.50197.762.27101.1798.412.27
293043-9304397.20397.85
395096-9509699.348100.01
490017-9001794.04294.67
593138-9313897.30297.95
693942-9394298.14298.79
45min195943-95943100.23297.482.31101.0798.302.31
292742-9274296.88897.70
394746-9474698.98299.81
489663-8966393.67294.46
592866-9286697.01897.83
693912-9391298.11198.93
极限195846-95846100.13197.412.33101.1498.392.33
293643-9364397.83098.80
394376-9437698.59599.59
489403-8940393.40094.34
592602-9260296.74297.72
693573-9357397.75798.74
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