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%
114.941755341755821760861754271757841756830.15
214.941755161750451752800.20
单位质量响应值RSD%判断
11759.2411732.260.17数据可信
供试品溶液-1276525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%
30min126013-2601313.21913.455.2113.2213.455.21
226770-2677013.60413.60
327489-2748913.96913.97
425412-2541212.91412.91
524691-2469112.54712.55
628433-2843314.44914.45
60min144778-4477822.75522.843.6222.7822.863.62
245891-4589123.32023.34
347266-4726624.01924.04
444280-4428022.50222.52
542403-4240321.54821.57
645085-4508522.91122.93
120min172404-7240436.79336.873.0036.8536.923.00
272891-7289137.04137.10
375784-7578438.51138.57
472713-7271336.95037.01
568949-6894935.03835.09
672540-7254036.86236.92
240min1113932-11393257.89758.112.0658.0258.232.07
2114052-11405257.95858.08
3117969-11796959.94860.08
4115327-11532758.60558.73
5110698-11069856.25356.37
6114132-11413257.99858.12
360min1141494-14149471.90372.041.6072.1272.261.60
2140411-14041171.35271.57
3146035-14603574.21074.44
4142071-14207172.19672.41
5139612-13961270.94671.16
6140994-14099471.64971.87
480min1160194-16019481.40581.421.0181.7481.761.01
2158630-15863080.61180.95
3163196-16319682.93183.28
4160465-16046581.54381.88
5159167-15916780.88381.21
6159671-15967181.14081.48
600min1171238-17123887.01887.191.0687.4987.661.06
2169945-16994586.36186.83
3174641-17464188.74789.24
4172180-17218087.49687.97
5171815-17181587.31187.77
6169636-16963686.20386.68
720min1178513-17851390.71490.841.0591.3391.461.05
2177523-17752390.21190.83
3181553-18155392.25992.90
4179708-17970891.32291.94
5179157-17915791.04291.65
6176133-17613389.50590.12
960min1185483-18548394.25694.531.3695.0395.301.36
2183123-18312393.05793.82
3189408-18940896.25197.04
4187205-18720595.13195.90
5187662-18766295.36496.12
6183271-18327193.13293.90
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1189280-18928096.18696.701.3297.1197.631.32
2187538-18753895.30196.22
3193645-19364598.40499.36
4191504-19150497.31698.25
5192102-19210297.62098.54
6187682-18768295.37496.30
1440min1191553-19155397.34197.811.3298.4398.901.32
2189447-18944796.27197.35
3195081-19508199.134100.25
4194089-19408998.63099.72
5194846-19484699.014100.10
6189808-18980896.45497.54
极限1191727-19172797.42997.801.4298.6899.051.42
2189170-18917096.13097.37
3195681-19568199.439100.72
4193832-19383298.49999.76
5194751-19475198.966100.21
6189550-18955096.32397.57
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%
114.941760011758941755501756541759531758100.12
214.941756141772791764460.67
单位质量响应值RSD%判断
11767.7411810.310.26数据可信
供试品溶液-1276525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%
30min126557-2655713.44613.473.3713.4513.473.37
226283-2628313.30713.31
328248-2824814.30214.30
425842-2584213.08413.08
525852-2585213.08913.09
626836-2683613.58713.59
60min144831-4483122.69822.701.7922.7222.721.78
244738-4473822.65122.67
345738-4573823.15723.18
445064-4506422.81622.84
543380-4338021.96321.99
645293-4529322.93222.95
120min175271-7527138.11037.372.0038.1737.432.00
273038-7303836.97937.04
374954-7495437.94938.01
474212-7421237.57437.63
571251-7125136.07536.13
674111-7411137.52337.58
240min1113390-11339057.41057.461.1057.5357.581.10
2112786-11278657.10457.23
3114355-11435557.89858.02
4114190-11419057.81557.94
5111430-11143056.41756.54
6114808-11480858.12858.25
360min1140559-14055971.16571.470.4871.3871.680.48
2140662-14066271.21871.43
3141663-14166371.72471.95
4141003-14100371.39071.61
5140801-14080171.28871.50
6142254-14225472.02472.24
480min1158410-15841080.20380.870.6780.5481.210.66
2159530-15953080.77181.11
3159347-15934780.67881.02
4159064-15906480.53580.87
5161009-16100981.51981.85
6160983-16098381.50681.85
600min1169285-16928585.71086.750.9786.1887.220.96
2171794-17179486.98087.45
3170970-17097086.56387.04
4169794-16979485.96786.44
5173522-17352287.85588.32
6172715-17271587.44687.92
720min1176814-17681489.52190.451.0090.1491.071.00
2179194-17919490.72691.34
3178023-17802390.13490.75
4176852-17685289.54190.16
5181416-18141691.85192.47
6179607-17960790.93691.56
960min1184675-18467593.50294.491.2094.2795.261.19
2187089-18708994.72495.49
3186236-18623694.29295.06
4184429-18442993.37794.14
5190604-19060496.50397.27
6186757-18675794.55695.33
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1188483-18848395.43096.721.3996.3597.641.38
2191984-19198497.20298.13
3190403-19040396.40297.33
4188588-18858895.48396.40
5195632-19563299.04999.98
6191097-19109796.75397.68
1440min1190854-19085496.63098.501.7197.7199.581.69
2194801-19480198.62899.71
3198464-198464100.483101.57
4191032-19103296.72097.80
5198155-198155100.327101.42
6193948-19394898.19699.29
极限1190886-19088696.64697.901.3297.8999.151.31
2194375-19437598.41399.66
3192734-19273497.58298.84
4191075-19107596.74297.98
5197804-197804100.149101.41
6193303-19330397.87099.13
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