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 15.001698471699791704021702571698621700690.15
2 15.031703891704401704140.03
单位质量响应值RSD%判断
11337.9311338.260.01数据可信
供试品溶液-25021203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%
30min128161-2816114.52114.924.8814.5214.924.88
230936-3093615.95215.95
326857-2685713.84913.85
429455-2945515.18815.19
529706-2970615.31815.32
628516-2851614.70414.70
60min151324-5132426.46526.162.3126.4926.192.31
250192-5019225.88125.91
348781-4878125.15425.18
451027-5102726.31226.34
552253-5225326.94426.97
650853-5085326.22226.25
120min180438-8043841.47742.202.0841.5542.272.08
280652-8065241.58841.66
380046-8004641.27541.34
484110-8411043.37143.44
583377-8337742.99343.06
682437-8243742.50842.58
240min1124612-12461264.25564.411.1364.3964.551.14
2124097-12409763.99064.13
3122858-12285863.35163.48
4125015-12501564.46364.60
5126224-12622465.08665.23
6126717-12671765.34165.48
360min1148336-14833676.48876.951.2376.7377.191.23
2148562-14856276.60576.85
3146375-14637575.47775.72
4150733-15073377.72477.97
5149984-14998477.33877.59
6151369-15136978.05278.30
480min1163531-16353184.32384.901.1684.7085.281.16
2163708-16370884.41584.79
3161978-16197883.52383.89
4166322-16632285.76386.14
5165302-16530285.23785.62
6167035-16703586.13086.51
600min1173281-17328189.35189.731.0989.8690.241.08
2173213-17321389.31689.83
3171624-17162488.49789.00
4175046-17504690.26190.78
5173778-17377889.60790.13
6177121-17712191.33191.85
720min1181214-18121493.44292.961.0194.1093.631.01
2179527-17952792.57293.23
3177915-17791591.74092.39
4181053-18105393.35994.03
5179043-17904392.32292.99
6182966-18296694.34595.02
960min1186077-18607795.94996.251.0496.7797.071.03
2186006-18600695.91396.73
3184271-18427195.01895.82
4188606-18860697.25398.08
5185646-18564695.72796.55
6189342-18934297.63398.46
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1190643-19064398.30498.351.0399.2899.341.04
2189801-18980197.86998.85
3188172-18817297.02997.99
4192901-19290199.468100.46
5189715-18971597.82598.81
6193203-19320399.624100.62
1440min1192271-19227199.14399.241.06100.28100.381.06
2191851-19185198.926100.07
3189640-18964097.78698.91
4194359-194359100.220101.37
5191393-19139398.69099.84
6195209-195209100.658101.82
极限1191982-19198298.99499.351.24100.30100.661.24
2191585-19158598.789100.09
3189839-18983997.88999.18
4194515-194515100.300101.62
5191631-19163198.813100.12
6196461-196461101.304102.63
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