依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.251817141821021832481827041826391824810.33
211.331807021798991803000.32
单位质量响应值RSD%判断
16220.5315913.501.36数据可信
长期24月-供试品溶液-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023122121118427318387918407698.1199.953.4196.37%～103.52%
2191133192273191703102.18
3196026196239196132104.54
417862017745217803694.89
5190119189644189882101.21
618530118525418527898.75
2023122221118225218306118265697.3599.871.7398.06%～101.67%
2192527192130192328102.51
3188958188354188656100.55
4188971187301188136100.27
518552618608718580699.03
618608418726418667499.50
2023122321118379518377718378697.96101.722.7498.81%～104.64%
2197038197195197116105.06
3194085194395194240103.53
418556518504018530298.76
5192908191577192242102.46
6192282192628192455102.58
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606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(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.121963631961891984811970961974211971100.47
211.071926931942571934750.58
单位质量响应值RSD%判断
17725.7217477.421.00数据可信
长期24月-供试品溶液-依折麦布-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2023122121118186118135718160992.6396.142.6193.50%～98.77%
218438018514918476494.24
319519619605719562699.78
418804618819918812295.95
519061819178819120397.53
618997718916918957396.69
2023122221118768318773818771095.7496.671.3895.27%～98.07%
219080719140219110497.48
318621118614518617894.96
419048719043719046297.15
519335019337119336098.63
618880418786418833496.06
2023122321118986918941418964296.7397.741.5696.15%～99.33%
219464519517919491299.42
319269619210019239898.14
418762518632218697495.37
519100619194019147397.66
619474919390619432899.12
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