恩格列净二甲双胍片项目信息
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101566-202301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2000
标示量(mg)5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%
110.059162991439914009145590988913820.26
210.029120491241912220.03
单位质量响应值RSD%判断
9092.749103.990.09数据可信
长期12月-供试品溶液-恩格列净-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211102715102396102556101.4598.591.7996.74%～100.44%
297433976639754896.49
310074310027810051099.42
4100167996269989698.82
598111983779824497.18
699660988439925298.18
2024030221198137991679865297.5997.930.9197.00%～98.85%
299381981869878497.72
310005210050110027699.19
498046987329838997.33
5995841001939988898.81
697931980299798096.92
20240303211102765102804102784101.6797.782.2695.46%～100.10%
298002973289766596.61
396513964279647095.43
497239977319748596.43
599490993459941898.34
699160993889927498.20
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.935089505047825093365102265072875081160.43
29.945099905093765096830.09
单位质量响应值RSD%判断
51169.7951275.960.15数据可信
长期12月-供试品溶液-二甲双胍-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121156713157060556886899.9597.981.4196.54%～99.43%
255056654939554998096.63
356554956482356518699.30
455894455546555720497.90
555017854987555002696.64
655405755550455478097.48
2024030221154996655727455362097.2797.511.0296.47%～98.55%
255228454649454938996.53
356061355941656001498.40
455925455512555719097.90
556121856200056160998.68
654977254589954783696.26
2024030321156502356710656606499.4697.341.2496.08%～98.60%
255087755002855045296.72
354590154525854558095.86
455294755127355211097.01
555487155517955502597.52
655366155554955460597.45
恩格列净二甲双胍片项目信息
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101566-202301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2000
标示量(mg)5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%
110.059292493441933029347493066932410.26
210.029217393393927830.93
单位质量响应值RSD%判断
9277.719259.780.14数据可信
长期12月-供试品溶液-恩格列净
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121196124953369573092.9594.341.4392.94%～95.75%
297906982969810195.26
398938988099887496.01
496728968209677493.97
597995980159800595.16
695478954959548692.72
2024030221198148977769796295.1295.481.1394.35%～96.60%
297579973149744694.62
398111976859789895.06
498450986169853395.68
510005710085610045697.54
697645977059767594.84
2024030321198559973939797695.1495.951.8894.06%～97.83%
298187980219810495.26
3995841002059989497.00
498439981729830695.46
510229010157210193198.98
696746965289663793.84
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
19.939239169283089240959293229310499273380.35
29.949264669212579238620.40
单位质量响应值RSD%判断
93387.5192943.860.34数据可信
长期12月-供试品溶液-二甲双胍
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121198788998832398810695.4596.450.6895.77%～97.13%
210025491001190100187096.78
310097541000596100517597.10
499909699263599586696.20
510067431002719100473197.06
699686099282399484296.10
2024030221110058591010746100830297.4097.491.1496.34%～98.65%
299364999413199389096.01
310017411009183100546297.13
410150641008093101157897.72
510327361025222102897999.40
610067751007504100714097.29
2024030321110234131006720101506698.0698.221.0397.17%～99.28%
210144141008754101158497.72
310231711020895102203398.73
410161121011183101364897.92
510335231035116103432099.92
61010608997310100395996.99
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