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)0
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4000
标示量(mg)2.5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%
110.328568585448861588589286275858920.40
210.398638686316863510.06
单位质量响应值RSD%判断
8322.878310.970.11数据可信
供试品溶液-2025120521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191837-9183799.18198.280.8899.1898.280.88
291398-9139898.70798.71
391584-9158498.90898.91
490146-9014697.35597.35
591186-9118698.47898.48
689887-8988797.07597.08
10min194187-94187101.71999.821.34101.8899.991.34
292611-92611100.017100.18
393363-93363100.829100.99
490723-9072397.97898.14
592075-9207599.43899.60
691638-9163898.96699.13
15min193171-93171100.62299.840.93100.96100.170.93
293219-93219100.674101.00
393209-93209100.663101.00
491371-9137198.67899.00
592033-9203399.39399.72
691659-9165998.98999.32
20min193945-93945101.458100.240.94101.96100.740.94
293453-93453100.926101.43
393246-93246100.703101.20
491710-9171099.04499.53
592028-9202899.38799.88
692525-9252599.924100.42
30min193697-93697101.190100.210.87101.86100.880.88
293564-93564101.046101.71
393115-93115100.561101.23
491603-9160398.92899.58
592395-9239599.784100.44
692385-9238599.773100.43
45min193537-93537101.017100.371.04101.86101.201.04
294074-94074101.597102.43
393755-93755101.252102.09
491743-9174399.07999.90
592235-9223599.611100.44
692284-9228499.664100.49
极限193310-93310100.772100.000.80101.78101.000.80
292766-92766100.184101.19
393518-93518100.996102.00
492126-9212699.493100.48
591606-9160698.93299.93
692263-9226399.641100.63
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)0
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4000
标示量(mg)2.5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%
110.328768987921877108793387977878460.16
210.398711586874869940.20
单位质量响应值RSD%判断
8512.218372.861.17数据可信
供试品溶液-2025120522批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188334-8833493.98594.742.8593.9894.742.85
290585-9058596.38096.38
386744-8674492.29392.29
490960-9096096.77996.78
585654-8565491.13391.13
691996-9199697.88197.88
10min190295-9029596.07196.912.0196.2397.072.01
292703-9270398.63398.79
388146-8814693.78593.94
492611-9261198.53598.70
590297-9029796.07396.23
692436-9243698.34998.51
15min190471-9047196.25997.321.8196.5897.641.82
292563-9256398.48498.81
389095-8909594.79595.10
492597-9259798.52198.85
590619-9061996.41696.73
693438-9343899.41599.74
20min189843-8984395.59097.061.8196.0797.541.81
292591-9259198.51499.00
389188-8918894.89395.36
492327-9232798.23398.72
590302-9030296.07996.55
693119-9311999.07699.57
30min190538-9053896.33097.441.4896.9798.081.48
292493-9249398.41099.06
389921-8992195.67396.30
492210-9221098.10998.76
590848-9084896.66097.29
693454-9345499.432100.09
45min190864-9086496.67797.441.3697.4798.241.37
292883-9288398.82599.64
389742-8974295.48396.27
491598-9159897.45898.27
591361-9136197.20598.00
693031-9303198.98299.81
极限190965-9096596.78497.421.6197.7498.381.62
292720-9272098.65199.63
389682-8968295.41996.36
491558-9155897.41598.39
590672-9067296.47297.43
693760-9376099.758100.75
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)0
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4000
标示量(mg)2.5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%
110.328613886447863718643386310863400.15
210.398552085046852830.40
单位质量响应值RSD%判断
8366.288208.181.35数据可信
供试品溶液-2025120621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min188490-8849095.91797.371.8395.9297.371.83
289847-8984797.38897.39
387895-8789595.27295.27
489327-8932796.82596.82
591168-9116898.82098.82
692246-9224699.98999.99
10min191464-9146499.141100.051.6799.30100.211.67
292486-92486100.249100.41
390554-9055498.15598.31
491206-9120698.86199.02
593488-93488101.335101.50
694635-94635102.578102.74
15min191482-9148299.161100.151.8099.49100.471.80
292852-92852100.646100.97
390884-9088498.51298.83
490852-9085298.47898.80
593157-93157100.976101.31
695118-95118103.102103.44
20min191865-9186599.576100.001.80100.07100.491.79
292497-92497100.261100.76
390636-9063698.24498.73
490436-9043698.02798.52
593283-93283101.113101.61
694797-94797102.754103.26
30min191721-9172199.420100.061.20100.08100.731.21
292906-92906100.704101.37
391299-9129998.96299.61
491045-9104598.68799.34
593192-93192101.014101.68
693729-93729101.596102.28
45min191977-9197799.697100.251.53100.52101.081.53
293077-93077100.889101.72
391397-9139799.06899.88
490660-9066098.27099.09
593250-93250101.077101.92
694535-94535102.470103.32
极限191893-9189399.60699.791.58100.59100.791.57
292084-9208499.813100.81
390259-9025997.83598.82
490804-9080498.42699.41
593254-93254101.081102.09
694103-94103102.002103.02
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)0
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4000
标示量(mg)2.5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%
110.328568585785858508582385564857410.14
210.398631785874860960.37
单位质量响应值RSD%判断
8308.248286.430.19数据可信
供试品溶液-G02PSP批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146124-4612449.93067.9616.0849.9367.9616.08
260504-6050465.49765.50
369758-6975875.51475.51
476071-7607182.34882.35
561872-6187266.97866.98
662323-6232367.46667.47
10min163258-6325868.47883.7110.3468.5683.8210.35
276596-7659682.91783.03
383302-8330290.17690.30
486491-8649193.62893.77
576475-7647582.78682.90
677841-7784184.26484.38
15min173925-7392580.02591.316.4880.2291.566.49
287210-8721094.40694.65
387566-8756694.79295.07
488971-8897196.31396.61
583769-8376990.68190.93
684634-8463491.61891.87
20min180527-8052787.17294.954.1487.5095.364.16
290403-9040397.86398.27
388603-8860395.91496.35
489560-8956096.95097.40
587818-8781895.06595.47
689379-8937996.75497.16
30min185841-8584192.92497.082.6893.4097.642.69
291555-9155599.11099.68
389315-8931596.68597.28
489803-8980397.21397.83
588803-8880396.13196.69
692770-92770100.425100.99
45min187730-8773094.96997.782.6395.6098.512.63
292274-9227499.888100.62
388546-8854695.85396.61
489906-8990697.32598.10
589511-8951196.89797.62
693997-93997101.753102.49
极限183622-8362290.52296.613.7091.3197.503.71
290968-9096898.47599.37
388667-8866795.98496.90
489356-8935696.73097.67
589216-8921696.57897.46
693659-93659101.388102.29
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