地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号2.0对照品来源EP对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数1系数4
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.162230895221949122309812221597222492122255770.24
210.092240627222662822336280.45
单位质量响应值RSD%判断
219052.85221370.470.75数据可信
供试品溶液-pH6.8(内含0.5%吐温20)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2025031021批118905321890300189041685.7692.125.3886.92%~97.31%
220633882060942206216593.55
320059992000744200337290.89
421973252196309219681799.66
519447521944150194445188.21
620860772085387208573294.62
2025031121批119422611935104193868287.9588.161.1187.14%~89.18%
219723451975863197410489.56
319109001917587191424486.84
419564211967487196195489.01
519334501936089193477087.77
619372451935440193634287.85
2025031221批119330221930895193195887.6588.121.6086.64%~89.59%
219203921917891191914287.07
319228791927385192513287.34
419808111988555198468390.04
519148701913984191442786.85
619736631982681197817289.74
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