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%
19.898161481575817118166181748816620.09
29.898157781631816040.05
单位质量响应值RSD%判断
8257.038251.160.06数据可信
供试品溶液-25010801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%
5min189059-8905996.81699.312.2396.8299.312.23
289312-8931297.09197.09
391791-9179199.78699.79
493262-93262101.385101.38
590683-9068398.58198.58
693995-93995102.182102.18
10min188983-8898396.73399.372.1296.8999.532.12
289885-8988597.71497.88
391693-9169399.67999.85
493502-93502101.646101.81
590631-9063198.52598.69
693745-93745101.910102.08
15min188527-8852796.23799.032.1896.5699.362.18
289665-8966597.47597.80
391304-9130499.25699.59
493395-93395101.529101.87
590332-9033298.20098.53
693331-93331101.460101.80
20min188243-8824395.92998.702.2396.4199.192.23
289205-8920596.97497.46
390844-9084498.75699.25
493197-93197101.314101.82
590172-9017298.02698.52
693085-93085101.192101.70
30min187934-8793495.59398.372.3296.2499.042.32
288846-8884696.58497.23
390662-9066298.55899.22
493030-93030101.133101.81
589650-8965097.45898.11
692836-92836100.922101.60
45min187519-8751995.14297.892.3695.9498.722.36
288397-8839796.09696.91
390002-9000297.84198.67
492884-92884100.974101.82
589281-8928197.05797.88
692216-92216100.248101.09
极限187009-8700994.58797.342.3195.5598.322.30
287997-8799795.66196.63
389546-8954697.34598.33
492217-92217100.249101.26
588765-8876596.49697.48
691699-9169999.686100.70
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%
19.894099641153411544099141029410650.21
29.894095241000409760.09
单位质量响应值RSD%判断
4152.174143.170.16数据可信
供试品溶液-25010804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%
5min146537-46537100.67799.661.75100.6899.661.75
245454-4545498.33498.33
344725-4472596.75796.76
446551-46551100.708100.71
546772-46772101.186101.19
646359-46359100.292100.29
10min146293-46293100.15099.501.31100.3299.661.31
245424-4542498.27098.43
345053-4505397.46797.63
446406-46406100.394100.56
546512-46512100.623100.79
646256-46256100.069100.24
15min146199-4619999.94699.111.31100.2899.441.31
245252-4525297.89798.23
344869-4486997.06997.39
446143-4614399.825100.16
546296-46296100.156100.49
646125-4612599.786100.12
20min146061-4606199.64898.841.39100.1599.341.38
245155-4515597.68898.18
344666-4466696.63097.12
446146-4614699.831100.33
546212-4621299.974100.48
645886-4588699.26999.77
30min145910-4591099.32198.491.4999.9999.161.49
244922-4492297.18497.84
344505-4450596.28196.93
446218-4621899.987100.66
546035-4603599.591100.26
645568-4556898.58199.25
45min145590-4559098.62997.901.3799.4698.731.37
244681-4468196.66297.48
344275-4427595.78496.59
445630-4563098.71599.55
545765-4576599.00799.84
645592-4559298.63399.46
极限145437-4543798.29897.411.5099.2998.401.50
244473-4447396.21297.19
343902-4390294.97795.94
445442-4544298.30899.31
545450-4545098.32699.33
645454-4545498.33499.33
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