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%
1 15.103396813392063391603398973400203395930.12
2 15.093401653401863401760.01
单位质量响应值RSD%判断
22489.6022543.140.17数据可信
供试品溶液-24091201-js2M-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%
30min151757-5175713.43912.933.3913.4412.943.37
248856-4885612.68612.69
348825-4882512.67712.68
60min148775-4877512.66412.462.4912.6912.492.49
246624-4662412.10612.13
348602-4860212.62012.64
120min190421-9042123.47822.712.9523.5222.752.95
285912-8591222.30722.35
386007-8600722.33222.37
240min185724-8572422.25822.101.9422.3422.181.94
283229-8322921.61121.69
386341-8634122.41922.50
360min1148840-14884038.64737.782.0038.7737.892.01
2143844-14384437.34937.46
3143798-14379837.33737.45
480min1143326-14332637.21536.901.2737.4037.081.27
2140040-14004036.36236.54
3142973-14297337.12337.30
600min1220784-22078457.32756.720.9957.5756.960.99
2218064-21806456.62156.86
3216525-21652556.22156.46
720min1218207-21820756.65856.061.0057.0056.391.01
2213943-21394355.55155.88
3215528-21552855.96256.30
960min1268406-26840669.69269.400.6470.1369.830.64
2268072-26807269.60570.03
3265316-26531668.89069.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1266431-26643169.17968.600.7569.7369.140.75
2263339-26333968.37668.92
3262798-26279868.23668.78
1440min1297713-29771377.30277.480.5577.9778.140.54
2300247-30024777.96078.61
3297225-29722577.17577.83
极限1297974-29797477.36976.481.0678.1777.271.06
2293784-29378476.28177.07
3291882-29188275.78876.57
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