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%
111.174717584710754714854713554709804713310.07
211.224703794707584705680.06
单位质量响应值RSD%判断
42196.1541940.110.44数据可信
加速2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
20240308211515239515143515191104.65101.832.0399.67%～103.99%
2496936496830496883100.93
3503286503081503184102.21
4503861502972503416102.26
5504141505302504722102.52
648427848471048449498.41
2024030921148612248623048617698.75100.614.1896.20%～105.02%
246467046445746456494.36
3521072520715520894105.81
4503089502931503010102.17
5512372512149512260104.05
648497948501748499898.51
20240310211497351497269497310101.02101.342.8398.34%～104.35%
2512312512489512400104.08
347319847330547325296.13
4510503510553510528103.70
5497646497561497604101.08
6502460502441502450102.06
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%
111.044390034357644362944361924359804366470.31
211.004352454352674352560.01
单位质量响应值RSD%判断
39551.3639568.730.04数据可信
加速2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
2024030821141522441498841510694.4495.174.1691.02%～99.32%
238687938680938684488.01
342699142671042685097.11
443569943511543540799.06
541512341635741574094.58
642990343010943000697.83
20240309211446209446319446264101.5397.973.6294.26%～101.69%
2441319441370441344100.41
342555542541642548696.80
440247740232440240091.55
543520843522443521699.01
643321743301243311498.53
2024031021140957840941340949693.1694.822.9091.94%～97.71%
242376942383042380096.42
342252242276342264296.15
439636039622839629490.16
541873241861741867495.25
642988342978042983297.79
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