瑞舒伐他汀钙依折麦布片项目信息
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%
111.414907534908214902394908324924964910280.18
211.364899604897754898680.03
单位质量响应值RSD%判断
43034.8843122.180.15数据可信
长期18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
2024030121149603949560049582098.35100.221.0799.10%～101.34%
2507645507785507715100.71
3507674507625507650100.70
4505094503225504160100.00
5511439511923511681101.50
6504458504543504500100.07
2024030221150189949954650072299.32100.771.7298.96%～102.59%
2521242519239520240103.19
349582749594849588898.36
4507676507686507681100.70
5512933510529511731101.51
6511549512380511964101.55
20240303211530936530157530546105.24100.892.3098.45%～103.32%
2507762508490508126100.79
350247850251550249699.67
449928149963349945799.07
549969750041750005799.19
6510711511327511019101.36
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院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%
111.144430124424084420964424544426804425300.08
211.214420574423194421880.05
单位质量响应值RSD%判断
39724.4239445.850.50数据可信
长期18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
2024030121142948542885942917297.3397.580.7996.78%～98.38%
242920442904942912697.32
342746542864242805497.08
443050943073643062297.66
543648543713443681099.07
642777342781242779297.02
2024030221143251743180343216098.0198.611.0797.51%～99.71%
243471743479943475898.60
342759642732442746096.94
443874443854143864299.48
543528243568543548498.76
644027544048244037899.87
2024030321143554643480643517698.6998.210.8597.34%～99.08%
243536843502243519598.70
343697043589143643098.98
442609542639342624496.67
543288843275543282298.16
643237843246843242398.07
瑞舒伐他汀钙依折麦布片项目信息
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%
111.414899334905864900914909744899084902980.10
211.364890214884994887600.08
单位质量响应值RSD%判断
42970.9043024.650.09数据可信
中间条件18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
2024030121149217149159049188097.75100.502.0098.39%～102.61%
250052049961150006699.38
3506105503884504994100.36
4506857507933507395100.83
5506934507862507398100.84
6521874523026522450103.83
2024030221149593749720549657198.68101.334.1796.90%～105.76%
2505277506150505714100.50
3536493536347536420106.60
4527876528330528103104.95
547812347839447825895.04
6512961515739514350102.22
20240303211507907507908507908100.94100.731.5799.07%～102.39%
2512130512354512242101.80
349965749933449949699.27
4516797518938517868102.92
549618249653549635898.64
6506458508176507317100.82
瑞舒伐他汀钙依折麦布片项目信息
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DSMF-387-240606对照品来源中检院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%
111.144431344423504424874424184431474427070.10
211.214421974415874418920.10
单位质量响应值RSD%判断
39740.3139419.450.58数据可信
中间条件18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
2024030121143784643690843737799.2198.360.9197.42%～99.29%
243549243683743616498.93
342789142787042788097.05
443740443721043730799.19
543149243079343114297.79
643216743160143188497.96
2024030221143576843496343536698.7599.360.8698.47%～100.26%
243299243353343326298.27
344010843861743936299.66
4442196442523442360100.34
543675043532243603698.90
6441409442603442006100.26
2024030321143498743380143439498.5398.321.1097.20%～99.45%
243276843310243293598.20
342859742818942839397.17
443659943621143640598.99
542774342877442825897.14
644119643986944053299.92
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