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500
标示量(mg)30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%
115.351697101694561694231696631700521696610.15
215.331697811695341696580.11
单位质量响应值RSD%判断
11052.8311067.060.10数据可信
供试品溶液-bc1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%
30min125052-2505213.24312.564.7413.2412.564.71
223018-2301812.16812.17
323207-2320712.26712.27
60min147818-4781825.27723.765.6525.3023.785.65
243014-4301422.73822.76
343999-4399923.25823.28
120min175048-7504839.67138.403.0239.7438.463.03
270756-7075637.40237.46
372134-7213438.13138.19
240min1114442-11444260.49558.542.9160.6358.672.91
2108542-10854257.37657.50
3109276-10927657.76457.89
360min1140169-14016974.09571.772.8274.3371.992.82
2133814-13381470.73570.95
3133329-13332970.47970.70
480min1156420-15642082.68580.202.7083.0480.552.70
2149836-14983679.20579.54
3148916-14891678.71979.06
600min1166813-16681388.17985.492.7688.6785.962.76
2159810-15981084.47784.94
3158535-15853583.80384.27
720min1173147-17314791.52788.742.7692.1789.362.76
2165952-16595287.72488.33
3164517-16451786.96587.57
960min1179890-17989095.09292.262.7195.8893.032.71
2172769-17276991.32792.08
3170957-17095790.37091.12
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1182784-18278496.62293.972.4997.5794.892.50
2176080-17608093.07893.98
3174427-17442792.20493.11
1440min1183358-18335896.92594.552.2498.0495.632.25
2177524-17752493.84194.90
3175713-17571392.88493.94
极限1183446-18344696.97194.642.2498.2495.872.25
2178027-17802794.10795.32
3175633-17563392.84194.05
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500
标示量(mg)30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%
115.351693741695381695781693711694051694530.06
215.331703871703811703840.01
单位质量响应值RSD%判断
11039.2811114.420.48数据可信
供试品溶液-bc2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%
30min121591-2159111.39611.571.3511.4011.571.33
222169-2216911.70111.70
321985-2198511.60411.60
60min141019-4101921.65022.504.4221.6722.524.40
242185-4218522.26622.29
344698-4469823.59223.61
120min168570-6857036.19236.731.3036.2536.791.31
270308-7030837.10937.17
369872-6987236.87936.94
240min1106388-10638856.15356.470.5156.2756.590.51
2107425-10742556.70056.82
3107172-10717256.56656.69
360min1133461-13346170.44270.250.2570.6570.460.25
2133038-13303870.21970.43
3132808-13280870.09770.31
480min1148340-14834078.29579.291.8878.6279.621.88
2153459-15345980.99781.33
3148850-14885078.56478.90
600min1158700-15870083.76383.840.5184.2284.300.50
2159709-15970984.29684.76
3158142-15814283.46983.93
720min1164995-16499587.08687.491.0387.6888.091.03
2167702-16770288.51589.12
3164564-16456486.85887.46
960min1171764-17176490.65990.960.6791.4091.710.67
2173652-17365291.65592.41
3171590-17159090.56791.31
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1200min1174837-17483792.28192.660.8293.1793.550.82
2177196-17719693.52694.43
3174606-17460692.15993.06
1440min1176572-17657293.19693.520.7194.2494.570.71
2178621-17862194.27895.34
3176351-17635193.08094.13
极限1176009-17600992.89993.410.7894.1094.620.78
2178548-17854894.23995.46
3176377-17637793.09394.30
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