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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.705059105011255026635029925017485028880.37
211.715003915001555002730.04
单位质量响应值RSD%判断
42981.8842721.860.43数据可信
影响因素10天-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
2024041021批150073949893149983599.6799.520.6198.89%～100.15%
249498749721349610098.93
349803749711549757699.22
449851049816349833699.37
549779949792249786099.28
6504640504745504692100.64
2024041021批148868448877248872897.4699.831.5298.24%～101.42%
2504792503847504320100.57
349685450004749845099.40
450064050104850084499.87
549905749998649952299.61
6512336511529511932102.08
l批1503005500939501972100.10101.651.6699.89%～103.42%
2519340519178519259103.54
3503866503822503844100.47
4519870519869519870103.67
5505574498103501838100.07
6511627512052511840102.07
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)5补液体积(ml)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%
111.394601194592354595204599354578674593350.20
211.454571944574364573150.04
单位质量响应值RSD%判断
40327.9239940.170.69数据可信
影响因素10天-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
2024041021批140752340698340725391.1093.712.3991.37%～96.06%
240672740851240762091.18
341855941659341757693.41
442466942375942421494.89
542424242591142507695.09
643184543183743184196.60
2024041021批141490541442341466492.7693.351.7191.68%～95.02%
241939541875741907693.74
342004142128342066294.10
441098941035241067091.86
541107940878140993091.70
642863442908942886295.93
l批142770242923042846695.8493.992.7391.30%～96.68%
242806142865942836095.82
340347840342240345090.25
440881840890140886091.46
542445541794342119994.22
643032743119243076096.36
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)5补液体积(ml)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5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.705006034992924998984989474989514995380.15
211.714985674982544984100.05
单位质量响应值RSD%判断
42695.5642562.770.23数据可信
影响因素10天-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
2024041021批1498666500075499370100.10101.961.9099.94%～103.99%
2521675521526521600104.55
3511543511501511522102.53
4502185501799501992100.62
5517366518062517714103.78
6499045500844499944100.21
2024041021批149147849207649177798.5896.683.2093.44%～99.93%
248582548791648687097.59
348554648643048598897.42
445234245133745184090.57
549386549403949395299.01
648355448343948349696.92
l批149489349535249512299.2595.982.3093.67%～98.29%
248347248357148352296.92
346148246120446134392.48
447607247654947631095.48
547736547722747729695.67
647932147949047940696.10
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)5补液体积(ml)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%
111.394564864571904564704560834558934564240.11
211.454558464555554557000.05
单位质量响应值RSD%判断
40072.3439799.130.49数据可信
影响因素10天-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
2024041021批139931639990039960889.8391.193.3388.01%～94.37%
242235142221842228494.93
342007141983841995494.41
440771240746840759091.63
538832138930238881287.41
639479739625139552488.91
2024041021批143114743306343210597.1496.221.0795.14%～97.30%
243028343027543027996.73
342142642236442189594.84
442713442778342745896.09
542361142347742354495.21
643292843295743294297.33
l批143732843749243741098.3395.832.1893.65%～98.02%
241928441922941925694.25
342681842678042679995.94
441462241499341480893.25
543686143677343681798.20
642278042269442273795.03
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