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)1.5补液体积(ml)1.5
对照品批号RSF-703-230318-D对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.374770954775934774964775574777284774940.05
211.384776224780154778180.06
单位质量响应值RSD%判断
41995.9541987.520.02数据可信
加速1月-供试品溶液-瑞舒伐他汀钙-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240408211498760498654498707101.48101.941.06100.81%～103.07%
2502977502988502982102.35
3503106502351502728102.30
4509398509838509618103.70
5496521495364495942100.92
6495913495711495812100.89
2024040921148136148147548141897.96100.431.3998.97%～101.90%
2492707492860492784100.28
3501105501286501196101.99
4498427498852498640101.47
5494687494612494650100.66
6492741492452492596100.24
2024041021148804648882848843799.3999.760.7798.96%～100.56%
2493796493597493696100.46
348706048726948716499.13
4493985494171494078100.54
548543948530948537498.77
6492986492718492852100.29
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)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.894303404307094308714304524307194306180.06
210.874299524303694301600.07
单位质量响应值RSD%判断
39542.5239573.140.06数据可信
加速1月-供试品溶液-依折麦布-pH7.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024040821143038043015743026897.8997.631.3596.24%～99.01%
243398543377843388298.71
341958841932541945695.43
443399543409743404698.75
542525542462942494296.68
643207143207543207398.30
2024040921142973143011742992497.8198.280.4497.83%～98.72%
243282943265043274098.45
343480343476943478698.92
443047643099843073798.00
543298943311343305198.53
643077843039143058497.96
2024041021141469741378841424294.2595.061.7393.34%～96.79%
241329941309841319894.01
341446241484841465594.34
441134641162841148793.62
542365642338942352296.36
642957143009042983097.79
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