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%
114.962036152034972034132040152032112035500.15
215.012037862042892040380.18
单位质量响应值RSD%判断
13606.2813593.470.07数据可信
供试品溶液-24071501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%
30min126040-2604011.53412.375.9111.5312.375.93
226639-2663911.80011.80
329525-2952513.07813.08
429925-2992513.25513.26
528682-2868212.70512.70
626790-2679011.86711.87
60min149481-4948121.91722.274.7821.9422.294.79
247715-4771521.13521.15
353337-5333723.62523.65
451824-5182422.95522.98
551752-5175222.92322.94
647497-4749721.03921.06
120min176983-7698334.09936.414.7834.1636.474.77
278641-7864134.83434.89
386059-8605938.11938.18
485919-8591938.05738.12
584759-8475937.54437.60
680882-8088235.82635.88
240min1119633-11963352.99155.593.5153.1055.713.51
2121895-12189553.99354.11
3130275-13027557.70557.83
4128390-12839056.87056.99
5129276-12927657.26257.38
6123561-12356154.73154.85
360min1149606-14960666.26768.532.3866.4768.742.38
2151982-15198267.32067.52
3158408-15840870.16670.39
4157115-15711569.59369.81
5158102-15810270.03170.25
6153040-15304067.78867.99
480min1169632-16963275.13877.321.8775.4577.641.88
2172183-17218376.26876.58
3177863-17786378.78479.12
4175828-17582877.88278.22
5177776-17777678.74579.08
6174073-17407377.10577.42
600min1182841-18284180.98982.761.2481.4383.221.25
2187569-18756983.08383.53
3189660-18966084.00984.48
4186951-18695182.80983.27
5188075-18807583.30783.77
6185940-18594082.36182.81
720min1190938-19093884.57585.811.1485.1586.401.15
2191745-19174584.93385.51
3197088-19708887.29987.91
4194293-19429386.06186.66
5194727-19472786.25386.86
6193555-19355585.73486.32
960min1199324-19932488.29089.290.9389.0090.030.94
2199914-19991488.55189.27
3204466-20446690.56791.32
4201312-20131289.17089.92
5202487-20248789.69190.44
6202034-20203489.49090.22
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1204753-20475390.69491.190.8491.5592.080.85
2204052-20405290.38491.25
3208934-20893492.54693.45
4205470-20547091.01291.91
5206538-20653891.48592.38
6205511-20551191.03091.91
1440min1206539-20653991.48591.830.6392.5092.860.64
2206147-20614791.31292.33
3209845-20984592.95094.01
4207139-20713991.75192.80
5207208-20720891.78292.83
6206990-20699091.68592.71
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%
114.962034082035572034692033042031832033840.08
215.012032442030262031350.08
单位质量响应值RSD%判断
13595.1913533.310.33数据可信
供试品溶液-24072401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%
30min128186-2818612.51812.427.0912.5212.427.09
227318-2731812.13212.13
327885-2788512.38412.38
428297-2829712.56712.57
531147-3114713.83313.83
624981-2498111.09411.09
60min151957-5195723.07522.113.8823.1022.143.88
250342-5034222.35722.38
350930-5093022.61922.64
450408-5040822.38722.41
548552-4855221.56221.59
646561-4656120.67820.70
120min184683-8468337.60936.623.1737.6736.683.17
283113-8311336.91136.97
384772-8477237.64837.71
483629-8362937.14137.20
580114-8011435.58035.64
678413-7841334.82434.88
240min1130222-13022257.83356.852.3857.9656.972.38
2129061-12906157.31757.44
3130789-13078958.08558.21
4129502-12950257.51357.63
5123336-12333654.77554.89
6125109-12510955.56255.67
360min1161452-16145271.70370.661.9771.9270.871.98
2159999-15999971.05771.27
3161598-16159871.76771.99
4161223-16122371.60171.82
5154546-15454668.63668.85
6155740-15574069.16669.37
480min1180521-18052180.17179.661.5380.5180.001.53
2179631-17963179.77680.11
3182715-18271581.14681.48
4181148-18114880.45080.79
5175525-17552577.95378.28
6176716-17671678.48278.80
600min1192075-19207585.30385.201.2685.7785.661.26
2192338-19233885.41985.89
3194774-19477486.50186.97
4193847-19384786.09086.56
5188797-18879783.84784.30
6189229-18922984.03984.49
720min1199121-19912188.43288.701.0389.0589.311.03
2200331-20033188.96989.58
3202822-20282290.07590.69
4200910-20091089.22689.84
5197905-19790587.89288.49
6197292-19729287.62088.21
960min1207081-20708191.96792.460.9892.7393.220.98
2208999-20899992.81993.58
3211645-21164593.99494.76
4208552-20855292.62093.38
5205880-20588091.43492.17
6207038-20703891.94892.68
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1211948-21194894.12894.310.9395.0495.220.94
2213713-21371394.91295.82
3215470-21547095.69396.62
4212170-21217094.22795.14
5210135-21013593.32394.22
6210707-21070793.57794.47
1440min1212329-21232994.29895.070.8695.3796.140.86
2214954-21495495.46396.53
3216910-21691096.33297.42
4214460-21446095.24496.32
5211919-21191994.11695.16
6213837-21383794.96796.01
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