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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
116.302224542223582223402223522221052223220.06
216.172218382223192220780.16
单位质量响应值RSD%判断
13639.3913733.950.49数据可信
供试品溶液-24072901-1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%
30min130006-3000613.20712.655.2913.2112.655.31
230232-3023213.30613.31
326705-2670511.75411.75
430022-3002213.21413.21
527711-2771112.19712.20
627797-2779712.23512.23
60min153423-5342323.51422.474.4623.5422.494.46
254162-5416223.83923.86
348236-4823621.23121.25
450544-5054422.24722.27
549863-4986321.94721.97
650058-5005822.03322.05
120min187917-8791738.69637.093.9838.7637.153.98
288657-8865739.02239.08
379914-7991435.17335.23
483170-8317036.60736.67
582712-8271236.40536.46
683290-8329036.65936.72
240min1138054-13805460.76358.682.9660.8958.802.96
2137553-13755360.54360.67
3128075-12807556.37156.48
4130635-13063557.49857.62
5131838-13183858.02758.14
6133813-13381358.89759.01
360min1169283-16928374.50872.542.2074.7472.762.21
2168871-16887174.32774.55
3160855-16085570.79971.01
4161483-16148371.07571.29
5163265-16326571.86072.07
6165127-16512772.67972.90
480min1189473-18947383.39581.561.7183.7581.901.71
2188181-18818182.82683.18
3181717-18171779.98180.31
4182256-18225680.21880.55
5184160-18416081.05681.39
6186035-18603581.88282.22
600min1201630-20163088.74687.061.6589.2487.541.65
2200308-20030888.16488.65
3194148-19414885.45385.91
4194125-19412585.44285.91
5196825-19682586.63187.10
6199820-19982087.94988.42
720min1208942-20894291.96490.371.4492.6090.991.45
2207709-20770991.42192.06
3202357-20235789.06689.67
4202242-20224289.01589.63
5203522-20352289.57890.19
6207147-20714791.17491.79
960min1217296-21729695.64193.901.5096.4394.671.50
2214670-21467094.48595.27
3210650-21065092.71693.47
4209451-20945192.18892.95
5211679-21167993.16993.93
6216238-21623895.17595.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1221540-22154097.50995.891.4298.4696.821.43
2218956-21895696.37297.32
3215058-21505894.65695.56
4213890-21389094.14295.05
5216940-21694095.48496.40
6220796-22079697.18198.11
1440min1223820-22382098.51296.821.4299.6397.911.42
2220916-22091697.23498.34
3217117-21711795.56296.62
4216424-21642495.25796.33
5218514-21851496.17797.25
6223083-22308398.18899.28
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240402对照品来源自制对照品使用方法直接使用
对照品含量(%)100.4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%
116.302221082222502220772222002221372221540.04
216.172225032225352225190.02
单位质量响应值RSD%判断
13629.0813761.220.69数据可信
供试品溶液-24072901-2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%
30min127486-2748612.09012.325.8412.0912.325.86
225218-2521811.09311.09
330000-3000013.19613.20
428566-2856612.56512.57
528975-2897512.74512.75
627755-2775512.20912.21
60min149888-4988821.94422.134.7721.9622.154.77
245881-4588120.18220.20
352877-5287723.25923.28
450885-5088522.38322.40
551664-5166422.72622.75
650726-5072622.31322.33
120min182849-8284936.44336.643.2436.5036.693.24
278406-7840634.48934.54
385665-8566537.68237.74
482770-8277036.40836.47
585438-8543837.58237.64
684585-8458537.20737.26
240min1130966-13096657.60957.771.5157.7357.891.51
2128723-12872356.62256.73
3133085-13308558.54158.66
4129494-12949456.96157.08
5133686-13368658.80558.93
6132095-13209558.10558.22
360min1162807-16280771.61571.250.8871.8371.460.88
2159540-15954070.17770.38
3163166-16316671.77271.99
4161069-16106970.85071.06
5162219-16221971.35671.58
6163013-16301371.70571.92
480min1184202-18420281.02680.170.9581.3680.500.95
2179040-17904078.75579.08
3183006-18300680.50080.84
4182518-18251880.28580.62
5182138-18213880.11880.46
6182639-18263980.33880.67
600min1196336-19633686.36385.171.2186.8385.641.21
2189780-18978083.47983.93
3195431-19543185.96586.44
4192575-19257584.70985.17
5193311-19331185.03285.50
6194372-19437285.49985.97
720min1203740-20374089.62088.241.2690.2388.841.26
2196356-19635686.37286.96
3202474-20247489.06389.68
4200280-20028088.09888.70
5200701-20070188.28388.90
6199998-19999887.97488.59
960min1212903-21290393.65091.841.4194.4192.601.41
2204157-20415789.80390.54
3210264-21026492.49093.26
4209543-20954392.17392.93
5207516-20751691.28192.04
6208334-20833491.64192.40
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1215752-21575294.90493.371.3395.8294.281.33
2207689-20768991.35792.24
3214559-21455994.37995.30
4211716-21171693.12894.04
5212336-21233693.40194.31
6211495-21149593.03193.94
1440min1216978-21697895.44394.211.1396.5295.281.13
2210292-21029292.50293.54
3216332-21633295.15996.24
4213589-21358993.95295.01
5214636-21463694.41395.48
6213258-21325893.80794.87
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