比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.993756033746583746733753653755713751740.13
211.023764033768193766110.08
单位质量响应值RSD%判断
34137.7634175.230.08数据可信
影响因素5天-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
2024122121批1388319388325388322101.91101.120.73100.34%～101.89%
2381868381948381908100.23
3381825382264382044100.26
4387122386776386949101.55
5387657387575387616101.73
6384986384962384974101.03
2024122121批1386552385847386200101.35101.871.12100.68%～103.07%
2386050385627385838101.26
3384886384142384514100.91
4394013394507394260103.47
5384925385228385076101.06
6392987393331393159103.18
l批1392185392429392307102.96101.931.41100.43%～103.43%
2383428383477383452100.63
3397383397830397606104.35
4386338386294386316101.38
5385296385262385279101.11
6385189385512385350101.13
比拉斯汀片项目信息
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D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.993759153755343752803757723758983756800.08
211.023774323780953777640.13
单位质量响应值RSD%判断
34183.8034279.850.20数据可信
影响因素5天-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
2024122121批1389524388530389027101.87100.591.7898.71%～102.47%
237295637233937264897.58
3382366383194382780100.24
4389036388683388860101.83
5390520390745390632102.29
638077038090138083699.73
2024122121批137413637435337424498.00100.892.5398.22%～103.57%
2394829394774394802103.38
337338037329237333697.76
4395797395839395818103.65
5385138385753385446100.93
6387930388244388087101.63
l批1392141391858392000102.65100.441.7798.58%～102.31%
238031538022438027099.58
337809037882137845699.10
437489837598637544298.31
5383994384639384316100.64
6391065390961391013102.39
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