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%
110.069239191995927319282092435924740.36
210.089243692432924340.01
单位质量响应值RSD%判断
9192.259170.040.18数据可信
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
2024112921批1102268101943102106100.0999.011.8997.05%～100.97%
2103411103247103329101.29
310068810072010070498.72
497847983049807696.14
599885995439971497.75
6102347101843102095100.08
2024120221批1101935102123102029100.0299.061.4197.59%～100.52%
299833995429968897.72
3102279102009102144100.13
410182810072610127799.28
5102321102167102244100.23
698850989529890196.95
2024120321批198388988179860296.6698.491.2797.19%～99.80%
299932995879976097.79
310181810180010180999.80
4100085998789998298.01
510077710092110084998.86
610172010198010185099.84
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20
标示量(mg)500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%
110.139944359976699971169983889998919975000.21
210.149965589941869953720.17
单位质量响应值RSD%判断
98469.8998162.920.23数据可信
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
2024112921批110788731074843107685898.5898.021.2896.71%～99.33%
210903441089314108982999.76
310722751070694107148498.09
410502221049714104996896.12
510609091061961106143597.17
610733231076063107469398.38
2024120221批110835811081845108271399.1198.031.1296.88%～99.18%
210588991060861105988097.02
310720681077424107474698.38
410739841074564107427498.34
510821631079717108094098.95
610532611052289105277596.37
2024120321批110542521056234105524396.6097.801.1696.61%～98.98%
210589271057811105836996.88
310820901083267108267899.11
410601911059074105963297.00
510713261072025107167698.10
610837161081035108237699.08
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%
110.069210591560919639152591756917820.28
210.089140591301913530.09
单位质量响应值RSD%判断
9123.469062.800.48数据可信
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
2024112921批198386984509841897.4198.901.7297.12%～100.68%
2101904102431102168101.12
399297992039925098.23
498049978519795096.95
510006610016210011499.09
6101640101672101656100.62
2024120221批1102347102551102449101.4098.402.1696.18%～100.62%
296442962259633495.35
399599991189935898.34
410075510100410088099.85
598190977989799496.99
699381995789948098.46
2024120321批197810980919795096.95100.191.9098.20%～102.18%
2102653102766102710101.66
3101163101734101448100.41
4102259102174102216101.17
510009210000010004699.02
6103263102684102974101.92
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20
标示量(mg)500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%
110.135328595339295326455320935332025329460.13
210.145326715323135324920.05
单位质量响应值RSD%判断
52610.6652514.000.14数据可信
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
2024112921批157542457590457566498.5799.221.5097.66%～100.77%
2588599588664588632100.79
357476057554957515498.48
456715856683956699897.08
557967758170158068999.43
6588967590018589492100.94
2024120221批1600571598746599658102.6899.631.9897.57%～101.69%
256768556708756738697.15
357503257362957433098.34
4589154588976589065100.86
557711057750457730798.85
658276258403258339799.89
2024120321批157026357081557053997.6999.851.4198.38%～101.32%
2593894593696593795101.67
358078258049458063899.42
4586584584870585727100.29
557922957907257915099.17
6589233588893589063100.86
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