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%
110.118237282092823128270182641824240.31
210.138231582448823820.12
单位质量响应值RSD%判断
8152.728132.480.18数据可信
供试品溶液-2025120521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%
5min192060-92060101.550101.270.96101.55101.270.96
291178-91178100.577100.58
392304-92304101.820101.82
491946-91946101.425101.42
592913-92913102.491102.49
690435-9043599.75899.76
10min192797-92797102.363101.920.63102.53102.090.63
292404-92404101.930102.10
392916-92916102.495102.66
492581-92581102.125102.29
592395-92395101.920102.09
691296-91296100.708100.87
15min192612-92612102.159101.670.70102.50102.010.70
292271-92271101.783102.12
392360-92360101.881102.22
492527-92527102.066102.40
592349-92349101.869102.21
690884-90884100.253100.59
20min192183-92183101.686101.460.69102.20101.960.69
292198-92198101.703102.21
392484-92484102.018102.53
492165-92165101.666102.18
592092-92092101.586102.10
690719-90719100.071100.57
30min191727-91727101.183101.942.53101.86102.622.52
291870-91870101.341102.02
392021-92021101.507102.19
491631-91631101.077101.76
596992-96992106.991107.67
690233-9023399.535100.20
45min190969-90969100.347100.180.86101.20101.030.86
291521-91521100.956101.80
391125-91125100.519101.37
490985-90985100.365101.21
591019-91019100.402101.26
689291-8929198.49699.33
极限190930-90930100.30499.991.15101.32101.001.14
292268-92268101.780102.79
390793-90793100.153101.17
490544-9054499.878100.89
590264-9026499.569100.59
689062-8906298.24399.24
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%
110.118329383752838668365983534836210.27
210.138289183214830520.28
单位质量响应值RSD%判断
8271.128198.620.63数据可信
供试品溶液-2025120522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%
5min192862-92862101.289101.301.31101.29101.301.31
290822-9082299.06499.06
392556-92556100.955100.96
493664-93664102.164102.16
594419-94419102.987102.99
692891-92891101.321101.32
10min193070-93070101.516101.200.86101.68101.370.86
291330-9133099.61899.78
393026-93026101.468101.64
492516-92516100.912101.08
593140-93140101.592101.76
693604-93604102.098102.27
15min192467-92467100.858100.730.86101.20101.070.86
291028-9102899.28999.62
392820-92820101.243101.58
491903-91903100.243100.58
592602-92602101.006101.35
693282-93282101.747102.09
20min192099-92099100.457100.340.84100.96100.840.84
290892-9089299.14099.64
392583-92583100.985101.49
491663-9166399.981100.49
591629-9162999.944100.45
693068-93068101.514102.02
30min191677-9167799.997100.010.81100.67100.680.81
290371-9037198.57299.23
392239-92239100.610101.28
491486-9148699.788100.46
591915-91915100.256100.93
692473-92473100.865101.54
45min191202-9120299.47899.500.85100.32100.340.85
290070-9007098.24499.07
391754-91754100.081100.92
490986-9098699.243100.08
590959-9095999.213100.06
692332-92332100.711101.56
极限190934-9093499.18698.900.79100.1999.900.79
289554-8955497.68198.67
391291-9129199.576100.58
490165-9016598.34799.35
590634-9063498.85999.87
691441-9144199.739100.75
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)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%
110.118339983367834918369083501834900.16
210.138356683581835740.02
单位质量响应值RSD%判断
8258.168250.150.07数据可信
供试品溶液-2025120621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%
5min190373-9037398.34298.411.4398.3498.401.43
289115-8911596.97396.97
390540-9054098.52498.52
488858-8885896.69396.69
591846-9184699.94599.94
691865-9186599.96699.97
10min192151-92151100.277100.151.66100.44100.311.66
290192-9019298.14598.31
392612-92612100.778100.94
490324-9032498.28998.45
594116-94116102.415102.58
692792-92792100.974101.14
15min191293-9129399.34399.911.8299.67100.241.82
290173-9017398.12498.45
392559-92559100.721101.05
489814-8981497.73498.06
594008-94008102.298102.63
693055-93055101.261101.60
20min191736-9173699.82599.551.42100.32100.051.43
289818-8981897.73898.23
391808-9180899.904100.40
490143-9014398.09298.58
593292-93292101.518102.03
692128-92128100.252100.76
30min191235-9123599.28099.241.5299.9499.901.52
289859-8985997.78398.43
391375-9137599.432100.10
489438-8943897.32597.98
593087-93087101.295101.97
692208-92208100.339101.01
45min190679-9067998.67598.701.6999.5099.531.69
288932-8893296.77497.59
391058-9105899.08799.92
489109-8910996.96797.78
593019-93019101.221102.07
691427-9142799.489100.33
极限190153-9015398.10398.311.4599.1099.301.45
288856-8885696.69197.67
390833-9083398.84399.84
488953-8895396.79797.77
592246-92246100.380101.39
691027-9102799.054100.06
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%
110.118157881425814668165781741815730.17
210.138351082883831960.54
单位质量响应值RSD%判断
8068.558212.831.26数据可信
供试品溶液-G02PSP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%
5min156029-5602961.82458.0413.6861.8258.0413.67
254276-5427659.89059.89
351217-5121756.51556.51
457996-5799663.99563.99
538788-3878842.80042.80
657316-5731663.24463.24
10min173658-7365881.27782.7110.5381.3882.8110.53
277284-7728485.27885.38
381863-8186390.33090.42
477939-7793986.00086.11
559802-5980265.98766.06
679203-7920387.39587.50
15min184571-8457193.31892.936.8393.5693.176.84
286016-8601694.91395.15
389734-8973499.01599.26
486131-8613195.04095.29
573031-7303180.58580.77
685851-8585194.73194.98
20min188693-8869397.86796.893.9998.2697.284.01
290751-90751100.138100.54
390958-90958100.366100.78
487894-8789496.98597.39
581359-8135989.77490.09
687195-8719596.21496.62
30min190812-90812100.20599.262.28100.7699.812.29
292918-92918102.529103.10
390640-90640100.015100.59
490127-9012799.449100.02
587455-8745596.50196.97
687790-8779096.87097.44
45min189895-8989599.19398.552.0899.9299.272.09
292299-92299101.846102.58
389670-8967098.94599.69
489330-8933098.57099.31
587255-8725596.28096.91
687444-8744496.48997.22
极限189567-8956798.83197.852.7099.7298.732.70
292182-92182101.717102.62
389390-8939098.63699.54
489023-8902398.23199.13
586231-8623195.15095.94
685694-8569494.55895.45
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