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%
110.128558685689855768590685601856720.17
210.178538485321853520.06
单位质量响应值RSD%判断
8465.618392.530.62数据可信
供试品溶液-24121201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%
5min190875-9087596.74197.942.3096.7497.942.30
293418-9341899.44899.45
390504-9050496.34696.35
490907-9090796.77596.78
595696-95696101.873101.87
690586-9058696.43396.43
10min191585-9158597.49798.612.1197.6698.772.11
293727-9372799.77799.94
391689-9168997.60897.77
491732-9173297.65397.81
596111-96111102.315102.48
690932-9093296.80296.96
15min191269-9126997.16098.362.2497.4898.682.24
293728-9372899.778100.11
391233-9123397.12297.45
491539-9153997.44897.77
596005-96005102.202102.54
690591-9059196.43996.76
20min191315-9131597.20998.362.4097.7098.852.40
293427-9342799.45899.96
391212-9121297.10097.58
491632-9163297.54798.03
596404-96404102.627103.14
690366-9036696.19996.68
30min190898-9089896.76597.992.1697.4198.642.16
293224-9322499.24299.91
390824-9082496.68797.33
491689-9168997.60898.26
595477-95477101.640102.32
690156-9015695.97696.62
45min190387-9038796.22297.582.0197.0398.402.01
292669-9266998.65199.48
390381-9038196.21597.02
491338-9133897.23498.05
594911-94911101.038101.89
690278-9027896.10596.91
极限191217-9121797.10597.451.9798.0798.431.98
292337-9233798.29799.29
390095-9009595.91196.88
491195-9119597.08298.06
594694-94694100.807101.83
689712-8971295.50396.47
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%
110.128541085310853708540685390853770.05
210.178536185365853630.01
单位质量响应值RSD%判断
8436.468393.610.37数据可信
供试品溶液-24121202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%
5min189741-8974195.69299.602.2795.6999.602.27
293499-9349999.69999.70
395400-95400101.726101.73
493854-93854100.078100.08
595416-95416101.743101.74
692550-9255098.68798.69
10min189679-8967995.62699.912.4895.79100.082.47
293722-9372299.937100.10
396137-96137102.512102.68
494133-94133100.375100.54
595656-95656101.999102.17
692875-9287599.03499.20
15min189857-8985795.81699.942.4196.13100.272.41
294582-94582100.854101.19
395867-95867102.224102.56
493923-93923100.151100.49
595624-95624101.965102.30
692505-9250598.63998.97
20min189574-8957495.51499.682.4395.99100.182.43
293175-9317599.35499.85
395876-95876102.234102.74
493880-93880100.105100.61
595508-95508101.841102.35
692873-9287399.03299.53
30min189325-8932595.24899.242.3795.8999.902.37
292771-9277198.92399.59
395389-95389101.714102.40
493462-9346299.660100.33
595087-95087101.392102.07
692362-9236298.48799.15
45min188769-8876994.65698.682.4695.4599.512.46
292419-9241998.54899.38
394887-94887101.179102.03
492849-9284999.00699.84
594762-94762101.046101.89
691566-9156697.63898.46
极限188472-8847294.33998.472.4495.2999.462.44
292173-9217398.28599.28
394560-94560100.831101.85
492779-9277998.93199.93
594497-94497100.763101.78
691570-9157097.64298.63
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)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%
110.128607886073859468590385955859910.10
210.178583485638857360.17
单位质量响应值RSD%判断
8497.138430.290.56数据可信
供试品溶液-25010301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%
5min188135-8813593.44095.791.9593.4495.791.96
292131-9213197.67697.68
392321-9232197.87897.88
489626-8962695.02195.02
591102-9110296.58596.59
688788-8878894.13294.13
10min188903-8890394.25496.481.8194.4196.641.81
292607-9260798.18198.34
392873-9287398.46398.63
490599-9059996.05296.21
591606-9160697.12097.28
689422-8942294.80494.96
15min188962-8896294.31796.681.9194.6397.001.91
292658-9265898.23598.56
393195-9319598.80499.13
490787-9078796.25196.57
592066-9206697.60797.93
689456-8945694.84095.16
20min188742-8874294.08396.471.8794.5596.951.87
292561-9256198.13298.62
392821-9282198.40898.90
490757-9075796.22096.70
591782-9178297.30697.79
689300-8930094.67595.15
30min188307-8830793.62296.031.9094.2596.671.90
291916-9191697.44898.10
392405-9240597.96798.62
490390-9039095.83196.47
591653-9165397.17097.82
688789-8878994.13394.76
45min187912-8791293.20395.611.9193.9996.411.91
291618-9161897.13297.95
391830-9183097.35798.18
489764-8976495.16795.97
591481-9148196.98797.80
688473-8847393.79894.59
极限187491-8749192.75794.931.8393.7095.901.82
291024-9102496.50397.48
391389-9138996.89097.87
489278-8927894.65295.61
590248-9024895.68096.65
687835-8783593.12294.07
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%
110.128545685484853748534185262853830.11
210.178568885588856380.09
单位质量响应值RSD%判断
8437.068420.650.14数据可信
供试品溶液-25010302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%
5min191640-9164097.55698.820.9397.5698.820.93
292993-9299398.99799.00
392417-9241798.38398.38
493708-9370899.75899.76
593850-9385099.90999.91
692354-9235498.31698.32
10min191814-9181497.74199.391.1297.9099.561.12
293835-9383599.893100.06
393089-9308999.09999.26
494265-94265100.351100.52
594535-94535100.638100.80
692649-9264998.63098.79
15min192137-9213798.08599.500.9898.4199.830.98
293902-9390299.964100.30
393188-9318899.20499.53
494231-94231100.314100.65
594525-94525100.627100.96
692815-9281598.80799.14
20min191678-9167897.59799.231.0298.0999.731.01
293601-9360199.644100.14
393203-9320399.22099.71
493983-93983100.050100.55
594210-94210100.292100.79
692614-9261498.59399.09
30min191390-9139097.29098.871.1197.9499.531.11
293277-9327799.29999.96
392547-9254798.52299.18
493611-9361199.654100.32
594223-94223100.306100.98
692188-9218898.14098.80
45min191002-9100296.87798.320.9797.6999.140.97
292820-9282098.81299.64
392022-9202297.96398.79
493087-9308799.09799.93
593349-9334999.375100.21
691848-9184897.77898.60
极限190598-9059896.44797.821.0397.4298.811.03
292363-9236398.32699.32
391375-9137597.27498.26
492513-9251398.48699.48
593156-9315699.170100.17
691344-9134497.24198.22
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