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)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%
110.953810763802503804483802613806323805330.09
210.933744633758113751370.26
单位质量响应值RSD%判断
34751.8734321.770.89数据可信
影响因素10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
2024121821批138341038404638372899.6099.741.0298.68%～100.80%
2386476386386386431100.30
3387505387613387559100.59
438285638275438280599.36
5387718387575387646100.62
637685337800937743197.97
2024121821批1385620385874385747100.1299.201.1198.05%～100.35%
2385822385531385676100.11
338522738506638514699.97
437995137964737979998.58
538123038200338161699.05
637521837511137516497.38
l批1387918388146388032100.72100.611.5598.98%～102.24%
238057838090938074498.83
3398758398594398676103.48
4387355387516387436100.56
5385619385970385794100.14
638510438495038502799.94
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)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%
110.953750733758303749413748963749893751460.11
210.933763943771063767500.14
单位质量响应值RSD%判断
34259.9134469.350.44数据可信
影响因素10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
2024121821批1387925387665387795101.1699.841.1198.68%～101.00%
238106837929938018499.17
338261238169438215399.69
438330838205238268099.82
5386813387304387058100.96
637708837596037652498.22
2024121821批137725737709137717498.3998.011.3296.66%～99.36%
237302237354837328597.37
3384570385259384914100.41
437162637086837124796.84
537392337208537300497.30
637478637474537476697.76
l批137997237955037976199.0699.421.3498.03%～100.82%
238290038246438268299.82
337801737887537844698.72
438283838325938304899.92
537412137373637392897.54
6389180388993389086101.49
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