恩格列净二甲双片项目信息
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%
110.149472294590951809480595121948840.28
210.149393493886939100.04
单位质量响应值RSD%判断
9357.409261.340.73数据可信
影响因素30天-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
2024120621批1994151001429977896.4696.462.2094.23%～98.69%
297941978759790894.66
397030969079696893.75
410112110013410062897.29
510024110004010014096.81
610369510273910321799.79
2024120621批198050971519760094.3696.131.5694.56%～97.71%
210086310030510058497.24
399043980219853295.26
498570985689856995.30
599544993949946996.17
610228310140010184298.46
l批198796990499892295.6494.962.3992.58%～97.33%
299381987629907295.78
393928934629369590.58
498041978119792694.67
510017010040110028696.96
699362994329939796.10
恩格列净二甲双片项目信息
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%
19.994976574956134982264985184988714977770.26
210.064966874962214964540.07
单位质量响应值RSD%判断
49827.5349349.300.69数据可信
影响因素30天-供试品溶液-二甲双-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024120621批153648053677053662597.4096.991.5895.39%～98.59%
252661552716152688895.63
352438752328252383495.07
454165653603553884697.80
553653252970253311796.76
654916854471054693999.27
2024120621批152373352345552359495.0396.581.3795.19%～97.96%
253624053439853531997.16
352755552588352671995.60
453255152767053011096.21
553356753161653259296.66
654446254412554429498.79
l批152763952748452756295.7595.561.9993.57%～97.54%
253382953366553374796.87
350661150471550566391.78
452901552917652909696.03
552948453207753078096.34
653303453119253211396.58
恩格列净二甲双片项目信息
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%
110.149477194993946259459294529947020.20
210.149384393462936520.29
单位质量响应值RSD%判断
9339.459235.900.79数据可信
影响因素30天-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
2024120621批194403947829459291.6695.592.3893.20%～97.97%
299387999129965096.57
399305987859904595.98
498182978889803595.00
510175110167910171598.57
699260983589880995.75
2024120621批11000459999810002296.9393.801.9291.92%～95.69%
295388956009549492.54
397267979039758594.57
494802949459487491.94
596718969679684293.85
696528954109596993.00
l批198758987819877095.7196.700.6196.09%～97.31%
299992998099990096.81
399296994559937696.30
410036610000610018697.09
510047810014010030997.21
69999410034010016797.07
恩格列净二甲双片项目信息
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%
19.994955784935824970434970674974484961440.33
210.064935294930484932880.07
单位质量响应值RSD%判断
49664.0649034.590.91数据可信
影响因素30天-供试品溶液-二甲双
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024120621批151603851294851449393.8396.311.4694.84%～97.78%
253082652743052912896.50
353161653042253101996.85
453187652989153088496.82
553704253747353725897.99
652771952362552567295.87
2024120621批154424653961754193298.8496.101.9094.19%～98.02%
251922252003251962794.77
353607053445653526397.62
451553051648451600794.11
552883852624152754096.21
652504751754752129795.07
l批152908352858052883296.4596.800.3096.50%～97.10%
253504453129353316897.24
353044953229853137496.91
453211652634952923296.52
553056053059953058096.77
653117653158853138296.91
恩格列净二甲双片项目信息
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%
110.149467794355945569432194187944190.21
210.149506694712948890.27
单位质量响应值RSD%判断
9311.549357.890.36数据可信
影响因素30天-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
2024120621批199669989389930495.7495.290.9994.30%～96.27%
299249986239893695.39
397101980259756394.07
41003789997010017496.58
599297990539917595.62
697891977859783894.33
2024120621批110045010018010031596.7295.741.1894.56%～96.92%
2997481002199998496.40
398622986699864695.11
410056910069410063297.02
598112974039775894.25
698818981179846894.94
l批1105745102382104064100.3396.472.5893.86%～99.07%
297035964799675793.29
399766997509975896.18
498120981179811894.60
51002289982210002596.44
610184710135410160097.96
恩格列净二甲双片项目信息
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%
19.999030169035959057289047359069879048120.18
210.069128719120229124460.07
单位质量响应值RSD%判断
90571.7790700.400.11数据可信
影响因素30天-供试品溶液-二甲双
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024120621批198243398016798130097.4496.730.8395.89%～97.57%
297523398464497993897.31
396017796474396246095.57
498207898137098172497.48
597118297234297176296.49
696671296897696784496.11
2024120621批197038897590697314796.6396.440.5195.93%～96.96%
297269697513497391596.71
397457796755497106696.43
497401397586097493696.81
596333295969396151295.48
697320697239597280096.60
l批199042098438498740298.0596.601.3695.23%～97.97%
295682295655295668795.00
397194496571496882996.20
496229096582496405795.73
597289496756297022896.34
699106698873398990098.30
恩格列净二甲双片项目信息
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%
110.149445694401942259460793774942930.34
210.149401393968939900.04
单位质量响应值RSD%判断
9299.119269.230.23数据可信
影响因素30天-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
2024120621批198826986099871895.7097.001.0495.95%～98.06%
210203810133510168698.57
310049310037510043497.36
410032110052910042597.35
599388991119925096.21
699814999439987896.82
2024120621批196051955419579692.8694.091.1392.98%～95.21%
297969981199804495.04
397710973979755494.57
495838954579564892.72
598186980759813095.13
697047973869721694.24
l批198667981139839095.3895.700.9894.71%～96.68%
298420987729859695.58
399839997379978896.73
498190986749843295.42
597174973669727094.29
6996061000389982296.77
恩格列净二甲双片项目信息
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%
19.999065059040969041939034509057759048040.15
210.069010019049019029510.31
单位质量响应值RSD%判断
90570.9789756.560.64数据可信
影响因素30天-供试品溶液-二甲双
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024120621批197406396885597145996.9797.560.9496.60%～98.53%
298998198235198616698.44
397507997169897338897.16
499044498670498857498.68
596514296424896469596.30
697815898218398017097.84
2024120621批195691694546895119294.9595.720.7295.00%～96.44%
296055996561696308896.14
396056695844595950695.78
494978995177895078494.91
596848896831696840296.67
695864196206096035095.86
l批197236795994396615596.4496.330.5995.73%～96.92%
295768596643596206096.03
397728096662697195397.02
496082896268296175596.00
596252395238895745695.57
696935197227797081496.91
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