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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.063518653518903517753517413516173517780.04
215.103519263517243518250.05
单位质量响应值RSD%判断
23358.4323299.670.18数据可信
供试品溶液-1224287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%
60min190404904469042523.13623.212.4523.1423.212.45
292604927549267923.71223.71
389940899008992023.00623.01
491799918169180823.48923.49
586681869078679422.20722.21
692803923639258323.68823.69
240min122944622880122912458.62258.881.2058.6658.921.20
223414523406323410459.89659.94
322874022816122845058.45058.49
422948422945322946858.71058.75
522672222692222682258.03358.07
623306123241123273659.54659.59
720min133987233970133978686.93587.920.7087.0788.050.70
234681334681534681488.73388.87
334448734436134442488.12288.26
434383434427134405288.02788.16
534192434258834225687.56787.70
634449334436234442888.12388.26
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.063508323504163512113500643501033505250.15
215.103502303500393501340.04
单位质量响应值RSD%判断
23275.2323187.680.27数据可信
供试品溶液-1236043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%
60min190474908559066423.29423.732.1523.2923.732.15
290417898449013023.15723.16
392031919259197823.63223.63
495406950229521424.46324.46
593928944149417124.19524.20
692009920149201223.64023.64
240min122626322586122606258.08259.812.1458.1259.852.14
223040122998323019259.14359.18
323459423455723457660.26960.31
423907123957623932461.48961.53
523648323709323678860.83860.88
622969922985622977859.03659.08
720min134324234371734348088.25090.061.9888.3990.201.97
234833334795234814289.44889.58
335605835621935613891.50291.64
435808135869535838892.08092.22
535467535527435497491.20391.34
634202534221334211987.90088.04
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数500
标示量(mg)30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%
115.063510323507793511893507613499313507380.14
215.103510333500433505380.20
单位质量响应值RSD%判断
23289.3823214.440.23数据可信
供试品溶液-1261778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%
60min190932907549084323.32022.572.5323.3222.582.53
287801888738833722.67622.68
388914890368897522.84022.84
487706880738789022.56222.56
583922842708409621.58821.59
687374876028748822.45822.46
240min122662622716922689858.24557.291.0658.2857.331.06
222312222319022315657.28557.32
322237722259122248457.11257.15
422433422434422433957.58857.63
521973221986121979656.42256.46
622272722227122249957.11657.15
720min134200834202634201787.79787.580.5787.9387.710.57
234086834007634047287.40087.53
333931633957533944687.13787.27
434310034285134297688.04388.18
534321534356934339288.14988.28
633867033876833871986.95087.08
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