氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.501868831869461868181869611869021869020.04
214.521866671867731867200.05
单位质量响应值RSD%判断
12889.7912859.500.17数据可信
加速1月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
6087549批117888917887617888298.2198.170.7897.37%~98.97%
218104218086018095199.34
317756517785417771097.56
417993018000617996898.80
517804417789817797197.71
617733917754517744297.42
6087549批117746417746317746497.4398.140.7997.33%~98.94%
218139918128718134399.56
317817417829017823297.85
417776717792317784597.64
517838717846117842497.96
617922517920517921598.39
6087549批118206818211918209499.9799.931.1798.71%~101.16%
2182653182768182710100.31
318026618031218028998.98
418016018031418023798.95
518097518095218096499.35
6185850185871185860102.04
6087549批117822517832017827297.8798.760.6998.05%~99.46%
217927317929217928298.43
318036818038718037899.03
417941117943317942298.50
518001018007218004198.84
618187518192318189999.86
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