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%
110.929398394162944009469094281943030.29
210.979320993497933530.22
单位质量响应值RSD%判断
8635.818509.851.04数据可信
加速6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
20240301211100595100522100558105.57105.451.82103.44%～107.46%
2100440101079100760105.79
3966829721896950101.79
4100803100256100530105.54
5101987101821101904106.99
6101764102102101933107.02
20240302211987349865498694103.62103.891.96101.76%～106.02%
2985139801798265103.17
3974689701497241102.09
4102901102513102707107.83
5978409793297886102.77
6989839883298908103.84
20240303211970759736297218102.07103.791.42102.25%～105.33%
2981299747697802102.68
3981569798098068102.96
4989519950999230104.18
5100792100871100832105.86
699742100283100012105.00
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%
19.044772464782224783634787174791964783490.16
29.114843124847714845420.07
单位质量响应值RSD%判断
52914.7153187.930.37数据可信
加速6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
2024030121153131553115353123490.1289.841.2188.70%～90.97%
252981652982552982089.88
351773051787851780487.84
452869352850352859889.68
553586153596153591190.92
653405053395153400090.59
2024030221152009152010352009788.2389.171.7287.57%～90.78%
252930552966652948689.83
351767151756551761887.81
454236154202254219291.98
552283752198452241088.63
652190352218952204688.56
2024030321151363051365151364087.1488.571.7086.99%～90.15%
251588751330551459687.30
351531651561351546487.45
452264452465452364988.84
553138553128753133690.14
653369953369453369690.54
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%
110.921018981021101021681024071020341021230.19
210.971045701044941045320.06
单位质量响应值RSD%判断
9351.929528.901.33数据可信
加速6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
2024030121196659967679671392.2193.231.2192.05%～94.40%
296310961539623291.75
398658986129863594.04
497718978149776693.21
597972979199794693.38
699528992629939594.77
2024030221198068978199794493.3894.071.0893.01%～95.13%
298116984589828793.71
3100042999389999095.33
49990010016710003495.38
597968977979788293.32
697870978069783893.28
2024030321198768990949893194.3295.331.0294.31%～96.35%
299434998569964595.00
3997711001419995695.30
410073510020010046895.79
599163992409920294.58
610177010171110174097.00
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%
19.047991087979727992097990317990777988790.07
29.118087998085028086500.03
单位质量响应值RSD%判断
88371.5788765.090.32数据可信
加速6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
2024030121194775994755094765496.3097.340.8096.52%～98.15%
295192295135195163696.70
396421896412296417097.98
495797395716395756897.31
595768295791295779797.33
696866796777296822098.39
2024030221195981196001095991097.5498.030.6497.37%～98.68%
296390996373696382297.94
397343797388497366098.94
497034796969197001998.57
595755395729995742697.29
696284796364096324497.88
2024030321196466096607896536998.1098.800.7398.05%～99.56%
297336097426697381398.96
397367197349297358298.93
497287697126297206998.78
596509396430196469798.03
6984540983821984180100.01
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