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%
110.929459994641948559463794592946650.12
210.979313493226931800.07
单位质量响应值RSD%判断
8668.968494.071.45数据可信
影响因素5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1963519655396452101.17104.142.67101.22%～107.05%
2100901100905100903105.83
3103784103847103816108.89
4979729768697829102.61
5984119840598408103.22
6982499834898298103.10
2024120621批11000459956999807104.69103.920.76103.09%～104.74%
2984559848798471103.28
3994089965299530104.39
4988199869598757103.58
5979489816898058102.85
6997349990099817104.70
2024120621批1101021100920100970105.90104.342.15101.99%～106.69%
2100504100309100406105.31
3102204102477102340107.34
4988409861098725103.55
5978139785597834102.62
6967049650996606101.33
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%
19.044803114803774786824787154788184793810.19
29.114797114801644799380.07
单位质量响应值RSD%判断
53028.8752682.550.47数据可信
影响因素5天-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
2024120621批150504550535650520086.0287.911.9986.08%～89.74%
252175952149352162688.82
353414753405853410290.95
451173051152951163087.12
551359651452451406087.53
651113851104151109087.03
2024120621批151853451848551851088.2988.380.7687.68%～89.08%
251661751665851663887.97
352154952165652160288.82
451782351768651775488.16
551401851463351432687.58
652545752534452540089.46
2024120621批152187052167452177288.8587.911.6286.42%～89.40%
251862151859151860688.31
352683952701652692889.72
451656251658051657187.96
551024951045251035086.90
650354250340850347585.73
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%
110.921029031027891026491027431028461027860.10
210.971056091051341053720.32
单位质量响应值RSD%判断
9412.649605.471.44数据可信
影响因素5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110032810059410046195.0993.791.3292.50%～95.08%
2100144996939991894.58
31003289996010014494.79
497156970829711991.93
598764981119843893.18
698140986799841093.15
2024120621批110108710075310092095.5395.281.8093.49%～97.08%
210035110029510032394.96
310060610083310072095.34
410290010318110304097.53
597528975149752192.31
610142610150310146496.04
2024120621批199823996739974894.4294.520.6993.84%～95.19%
210060510036210048495.11
39999510027610013694.79
498830986629874693.47
599380995449946294.15
610035410068810052195.15
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%
19.047957317954987945167936697937257946280.13
29.118115088113208114140.02
单位质量响应值RSD%判断
87901.3389068.500.94数据可信
影响因素5天-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
2024120621批196444796411496428098.0896.980.7396.24%～97.72%
295888095833895860997.51
395315195329895322496.96
494588094525394556696.18
595071195013295042296.67
694807894896894852396.48
2024120621批196554596495496525098.1897.821.4796.31%～99.32%
296228596204196216397.87
396104696165196134897.79
497535297476897506099.18
593514193472493493295.10
697132997071797102398.77
2024120621批195603495574095588797.2397.400.6096.80%～98.01%
296696396753596724998.39
395749395806895778097.42
495138595145995142296.78
595355495279295317396.95
695992596036396014497.66
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%
110.929366493302935839348693610935290.16
210.979340792966931860.34
单位质量响应值RSD%判断
8564.938494.620.59数据可信
影响因素10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1968759692796901102.24102.651.79100.73%～104.57%
2972569731397284102.65
3100297100628100462106.00
4967159665196683102.01
5971159735197233102.59
6949249542095172100.42
2024120621批193407932759334198.49102.612.7299.69%～105.53%
2983529796898160103.57
3100161100693100427105.97
4952409525795248100.50
5993439938399363104.84
6971579674396950102.30
2024120621批1951349514695140100.39104.342.21101.93%～106.75%
2983649815098257103.68
3100592100639100616106.16
4100053100309100181105.71
5982109817498192103.61
6100846101016100931106.50
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%
19.044738994745364742074734544742094740610.09
29.114800374798354799360.03
单位质量响应值RSD%判断
52440.3852682.330.33数据可信
影响因素10天-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
2024120621批150894950932150913587.1886.851.3685.61%～88.08%
250672850657450665186.75
351747551686351716988.55
450667350623150645286.72
550806850808750807887.00
649576349565749571084.88
2024120621批150144850198850171885.9187.371.3286.16%～88.58%
251004151019651011887.35
352071452061652066589.15
450840550828150834387.04
551503151496251499688.18
650605450552250578886.61
2024120621批150906550939950923287.2088.321.2387.18%～89.45%
250913850989650951787.24
352469652446852458289.82
451913051947351930288.92
551241151218851230087.72
651978251974751976489.00
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%
110.921032071028331031601032571029791030870.18
210.971051541051311051420.02
单位质量响应值RSD%判断
9440.209584.501.08数据可信
影响因素10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199710999289981994.4594.181.0593.14%～95.21%
297721978589779092.53
398817992929905493.72
410073210053110063295.22
599542993589945094.10
610037010053310045295.05
2024120621批110179610177510178696.3194.111.7792.37%～95.85%
210018610013010015894.77
397133973429723892.01
410073310045610059495.18
599305993609933293.99
697598977429767092.41
2024120621批199917998689989294.5293.791.8292.00%～95.57%
210146610137810142295.96
399860998559985894.48
499698996369966794.30
596798968569682791.62
697009971359707291.85
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%
19.047944337945737948007946557947687946460.02
29.118053068057208055130.04
单位质量响应值RSD%判断
87903.3288420.750.42数据可信
影响因素10天-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
2024120621批195898995758195828597.8397.340.7696.56%～98.11%
294075894062494069196.03
395217095262695239897.23
495377495332195354897.34
595353095402895377997.37
696220396195796208098.21
2024120621批196744496714596729498.7597.041.2595.78%～98.31%
295289295304095296697.28
393618993505293562095.51
496016996017496017298.02
594198594275594237096.20
694577094484394530696.50
2024120621批195265095274495269797.2697.201.2695.93%～98.48%
296814896794696804798.82
395258495307095282797.27
496063996062396063198.07
593422193375893399095.35
694463094485594474296.44
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