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%
1 14.941727431732981727041721281731551728060.27
2 14.941731641728761730200.12
单位质量响应值RSD%判断
11566.6711580.990.09数据可信
供试品溶液-1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%
30min124596-2459612.68512.602.2812.6812.602.29
224200-2420012.48012.48
324969-2496912.87712.88
423447-2344712.09212.09
524519-2451912.64512.64
624882-2488212.83212.83
60min147113-4711324.29723.572.1224.3223.592.12
245187-4518723.30423.32
345835-4583523.63823.66
444301-4430122.84722.87
546321-4632123.88823.91
645494-4549423.46223.48
120min176298-7629839.34839.181.4939.4139.241.50
276010-7601039.20039.26
376068-7606839.22939.29
473789-7378938.05438.11
576991-7699139.70539.77
676661-7666139.53539.60
240min1119356-11935661.55461.261.0761.6861.391.07
2119472-11947261.61461.74
3118923-11892361.33061.46
4116248-11624859.95160.07
5119400-11940061.57661.70
6119363-11936361.55761.68
360min1145170-14517074.86674.630.5275.1074.860.51
2145135-14513574.84875.08
3143510-14351074.01074.24
4145582-14558275.07975.30
5144349-14434974.44374.67
6144555-14455574.54974.78
480min1161600-16160083.34082.401.0983.6982.751.09
2160465-16046582.75483.11
3158496-15849681.73982.09
4157495-15749581.22381.57
5158920-15892081.95782.31
6161720-16172083.40283.75
600min1171056-17105688.21686.900.8988.7187.390.89
2168862-16886287.08587.58
3167860-16786086.56887.06
4167093-16709386.17286.65
5167189-16718986.22286.71
6169001-16900187.15687.65
720min1176485-17648591.01689.521.1991.6690.161.19
2174752-17475290.12290.76
3171609-17160988.50189.13
4172425-17242588.92289.55
5171435-17143588.41289.05
6174827-17482790.16190.80
960min1181253-18125393.47591.831.2394.2792.611.23
2178619-17861992.11792.90
3175857-17585790.69291.47
4176994-17699491.27992.05
5175916-17591690.72391.50
6179729-17972992.68993.48
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1184142-18414294.96593.301.3095.9194.231.30
2182033-18203393.87794.82
3178573-17857392.09393.02
4179745-17974592.69793.62
5178414-17841492.01192.94
6182531-18253194.13495.08
1440min1185394-18539495.61193.731.4196.7294.821.40
2182861-18286194.30495.40
3178502-17850292.05693.14
4181035-18103593.36394.44
5179552-17955292.59893.68
6183162-18316294.45995.56
极限1185494-18549495.66294.041.8296.9395.291.81
2186821-18682196.34697.60
3178772-17877292.19593.43
4180609-18060993.14394.38
5179364-17936492.50193.74
6183014-18301494.38395.64
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%
1 14.941727001731311728371727641730941729050.12
2 14.941729311730661729980.06
单位质量响应值RSD%判断
11573.2911579.520.04数据可信
供试品溶液-2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%
30min123999-2399912.37413.052.7912.3713.052.80
225280-2528013.03413.03
325164-2516412.97512.97
425833-2583313.32013.32
525696-2569613.24913.25
625871-2587113.33913.34
60min143827-4382722.59723.432.0122.6223.452.01
245212-4521223.31123.33
345910-4591023.67123.69
446414-4641423.93123.95
546001-4600123.71823.74
645279-4527923.34623.37
120min174858-7485838.59739.952.7938.6640.012.79
277320-7732039.86639.93
376914-7691439.65739.72
480869-8086941.69641.76
578979-7897940.72240.78
675947-7594739.15839.22
240min1116420-11642060.02660.470.5760.1560.600.57
2118005-11800560.84360.97
3116614-11661460.12660.25
4117411-11741160.53760.67
5117971-11797160.82660.96
6117269-11726960.46460.59
360min1141701-14170173.06173.470.6273.2873.700.62
2143124-14312473.79574.02
3142225-14222573.33173.56
4141335-14133572.87273.10
5143454-14345473.96574.20
6143152-14315273.80974.04
480min1157839-15783981.38281.490.6581.7381.840.65
2158667-15866781.80982.16
3157723-15772381.32281.67
4156278-15627880.57780.93
5159144-15914482.05582.41
6158644-15864481.79782.15
600min1167690-16769086.46186.100.8686.9486.590.85
2167550-16755086.38986.88
3166704-16670485.95386.44
4164506-16450684.81985.31
5168716-16871686.99087.48
6166789-16678985.99686.48
720min1173122-17312289.26288.930.8189.8989.560.81
2173104-17310489.25389.88
3172468-17246888.92589.55
4169708-16970887.50288.13
5173480-17348089.44690.08
6172936-17293689.16689.80
960min1179465-17946592.53291.660.8493.3192.440.83
2177896-17789691.72392.50
3178481-17848192.02592.80
4175044-17504490.25391.03
5178072-17807291.81492.60
6177688-17768891.61692.39
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1181979-18197993.82892.801.0794.7693.741.06
2179851-17985192.73193.66
3180661-18066193.14994.08
4176444-17644490.97591.90
5181119-18111993.38594.32
6179896-17989692.75493.69
1440min1183435-18343594.57993.271.1595.6694.361.14
2181264-18126493.46094.55
3180888-18088893.26694.35
4177100-17710091.31392.39
5181556-18155693.61094.70
6181186-18118693.42094.51
极限1182617-18261794.15792.941.0295.4094.181.02
2180124-18012492.87294.12
3180114-18011492.86794.11
4177314-17731491.42392.65
5181742-18174293.70694.96
6179613-17961392.60993.85
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