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D240501对照品来源自制对照品使用方法直接使用
对照品含量(%)97.44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%
1 15.001707831701101702311704021702831703620.16
2 15.031711031709461710240.07
单位质量响应值RSD%判断
11357.4711378.840.14数据可信
供试品溶液-25021201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%
30min127213-2721313.99513.194.1714.0013.194.17
224044-2404412.36512.37
325943-2594313.34213.34
426171-2617113.45913.46
525159-2515912.93912.94
625358-2535813.04113.04
60min147489-4748924.42323.583.2324.4523.613.23
243394-4339422.31722.34
346181-4618123.75023.77
447081-4708124.21324.24
545099-4509923.19323.22
645896-4589623.60323.63
120min175448-7544838.80138.381.9438.8738.441.94
272290-7229037.17737.24
375525-7552538.84138.90
476228-7622839.20239.27
573681-7368137.89337.95
674556-7455638.34338.40
240min1116166-11616659.74259.190.9759.8759.320.98
2114990-11499059.13759.26
3115946-11594659.62959.76
4115878-11587859.59459.72
5113344-11334458.29058.41
6114288-11428858.77658.90
360min1137761-13776170.84870.820.8971.0871.050.89
2137874-13787470.90671.12
3138801-13880171.38271.61
4139223-13922371.59971.83
5136255-13625570.07370.29
6136367-13636770.13170.35
480min1151610-15161077.97078.070.6478.3278.410.64
2152794-15279478.57978.92
3152124-15212478.23478.58
4152768-15276878.56578.91
5151240-15124077.78078.12
6150274-15027477.28377.62
600min1160527-16052782.55682.480.8183.0382.950.80
2161245-16124582.92583.39
3160942-16094282.76983.24
4161887-16188783.25583.73
5158868-15886881.70382.17
6158765-15876581.65082.12
720min1165559-16555985.14485.360.8485.7685.970.83
2167331-16733186.05586.66
3166644-16664485.70286.31
4167503-16750386.14386.76
5164643-16464384.67285.28
6164248-16424884.46985.07
960min1171256-17125688.07388.350.8288.8389.100.81
2173181-17318189.06389.81
3172404-17240488.66489.42
4173326-17332689.13889.90
5170676-17067687.77588.52
6169920-16992087.38688.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1174638-17463889.81389.900.6890.7290.800.68
2175793-17579390.40791.30
3175124-17512490.06390.97
4176281-17628190.65891.57
5173845-17384589.40590.30
6173173-17317389.05989.95
1440min1175879-17587990.45190.630.6091.5091.680.61
2176945-17694590.99992.05
3176436-17643690.73791.79
4177834-17783491.45692.52
5175200-17520090.10291.14
6175099-17509990.05091.09
极限1176055-17605590.54190.600.6791.7491.800.67
2176508-17650890.77491.97
3176554-17655490.79892.00
4177996-17799691.54092.75
5175427-17542790.21891.41
6174518-17451889.75190.94
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