乌帕替尼缓释片项目信息
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5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
115.081733631736221741401741411732971737130.24
215.121738991735871737430.13
单位质量响应值RSD%判断
11519.4311490.940.18数据可信
供试品溶液-25022801批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min127736-2773614.49313.992.3214.4914.002.31
226714-2671413.95913.96
326594-2659413.89713.90
426984-2698414.10014.10
525815-2581513.49013.49
626849-2684914.03014.03
60min149731-4973125.98725.432.3026.0125.462.31
249175-4917525.69625.72
348539-4853925.36425.39
449360-4936025.79325.82
546575-4657524.33824.36
648642-4864225.41825.44
120min180470-8047042.04941.862.2042.1241.922.19
278419-7841940.97841.04
380429-8042942.02842.09
483261-8326143.50843.57
578825-7882541.19041.25
679257-7925741.41641.48
240min1120515-12051562.97563.341.8963.1163.471.89
2119545-11954562.46862.60
3124735-12473565.18065.32
4123316-12331664.43964.58
5119067-11906762.21862.35
6120074-12007462.74462.88
360min1149642-14964278.19579.341.8978.4479.581.89
2150042-15004278.40478.64
3156357-15635781.70481.95
4154333-15433380.64680.89
5151198-15119879.00879.24
6149407-14940778.07278.31
480min1164667-16466786.04687.761.7886.4288.131.78
2166184-16618486.83987.21
3171550-17155089.64390.02
4170342-17034289.01289.39
5169830-16983088.74489.11
6165053-16505386.24886.62
600min1174205-17420591.03092.912.1291.5593.442.12
2175130-17513091.51492.03
3181646-18164694.91995.45
4179901-17990194.00794.54
5181956-18195695.08195.60
6174001-17400190.92491.44
720min1179309-17930993.69895.411.8494.3796.091.83
2180944-18094494.55295.22
3186558-18655897.48598.17
4185092-18509296.71997.41
5184941-18494196.64197.31
6178717-17871793.38894.05
960min1185122-18512296.73598.251.9597.5699.081.94
2185507-18550796.93697.76
3192410-192410100.543101.39
4190740-19074099.671100.52
5190649-19064999.623100.46
6183718-18371896.00196.82
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190281-19028199.431100.821.85100.42101.821.84
2190593-19059399.594100.58
3197170-197170103.031104.05
4195128-195128101.964102.98
5195909-195909102.372103.37
6188576-18857698.54099.52
1440min1189894-18989499.229100.661.69100.38101.821.69
2190508-19050899.550100.70
3196314-196314102.583103.77
4194701-194701101.741102.92
5195540-195540102.179103.35
6188820-18882098.66799.81
极限1189560-18956099.054100.471.67100.37101.801.66
2190480-19048099.535100.85
3195865-195865102.349103.71
4194304-194304101.533102.89
5195088-195088101.943103.28
6188340-18834098.41799.73
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