比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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%
111.081893451894481897581898121892121895150.14
211.001897531895201896360.09
单位质量响应值RSD%判断
17104.2417239.640.56数据可信
加速2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
1批118964818947218956098.9599.432.0697.28%～101.58%
219126719141819134299.88
318971518986118978899.07
4195962196234196098102.37
5192031191878191954100.20
618400618415918408296.09
1批1194015193886193950101.2598.962.2596.63%～101.29%
218937318948518942998.89
319021019020619020899.29
418609718563518586697.03
518363118375318369295.89
6194449194146194298101.43
1批118662418630018646297.3498.471.2497.20%～99.74%
219126019131319128699.86
318556018585518570896.94
418801118787018794098.11
518956118937318946798.91
619083719105519094699.68
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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%
111.081897351902771901241900681899711900350.11
211.001899181900691899940.06
单位质量响应值RSD%判断
17151.1717272.180.50数据可信
加速2月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批119107819100619104299.50100.171.4998.61%～101.73%
2192915192654192784100.40
319164119166519165399.82
4197788197530197659102.94
519151919167119159599.79
618931918911518921798.55
1批1195367195184195276101.7099.361.6497.65%～101.06%
219003719005019004498.98
319192819193919193499.96
418628518657718643197.10
518854118857818856098.20
6192333192409192371100.19
1批118692718710818701897.4099.170.9698.17%～100.17%
219130419151519141099.69
319011719031219021499.07
419066519135419101099.48
5192424192227192326100.17
619061719031019046499.20
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