贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.199736359721929725469722289720179725240.07
210.279706919720909713900.11
单位质量响应值RSD%判断
95439.0694585.200.64数据可信
供试品溶液-pH4.5(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批178600379136178868282.7899.658.7990.45%～108.84%
2975531975625975578102.39
3101066410110211010842106.10
4101128110171141014198106.45
594102494160394131498.80
6963624967831965728101.36
1批1961134964037962586101.03102.031.65100.27%～103.79%
294796894358994577899.27
3972198973160972679102.09
4987246985093986170103.51
5988932988404988668103.77
6973190979891976540102.49
1批187159487654087406791.7498.343.8294.40%～102.28%
293748093895293821698.47
3970781971140970960101.91
4968051963730965890101.38
595433794824795129299.84
692045392207792126596.69
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.192562462559422563512567962559962562660.14
210.272553752570282562020.46
单位质量响应值RSD%判断
25148.7724946.640.58数据可信
供试品溶液-pH6.6
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批123318623755223536993.7195.651.2594.40%～96.90%
223923723943323933595.29
324408323860424134496.09
424005523855823930695.27
524205224210124207696.38
624404824403224404097.16
1批124748124473424610897.9895.082.3392.76%～97.41%
223407923391023399493.16
324455924500224478097.45
423272323311023291692.73
523545023658523601893.97
623886123945523915895.22
1批123715823800623758294.5993.920.8293.12%～94.73%
223720723501323611094.00
323444423373723409093.20
423012223672923342692.93
523766423919223842894.92
623587423582023584793.90
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