二甲双胍恩格列净片项目信息
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%
19.99100219100333100712997101003291002610.36
210.069905498727988900.24
单位质量响应值RSD%判断
10036.149830.021.47数据可信
稳定性考察-加速3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
2024120421199958996929982590.4689.840.8689.03%～90.64%
299622990139931890.00
399394991539927489.96
4100140996599990090.53
597343978019757288.42
699307985919894989.66
2024120521199821998609984090.4789.541.8087.86%～91.22%
210129510093310111491.63
397639975969761888.46
497962978179789088.70
596429964609644487.39
6100342996209998190.60
2024120621197462983729791788.7389.893.1386.94%～92.84%
210404310449210426894.48
398013977109786288.68
496539961649635287.31
510212610132710172692.18
697141970099707587.97
二甲双胍恩格列净片项目信息
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%
110.416061526055236069326056596111416070810.39
210.486018366013966016160.06
单位质量响应值RSD%判断
58317.1057406.111.12数据可信
稳定性考察-加速3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
2024120421163045163015763030498.0598.210.7797.43%～99.00%
263524763312763418798.65
363188663022663105698.16
463693163685163689199.07
562318462247762283096.88
663522663089963306298.47
2024120521163461263646263553798.8698.421.3996.99%～99.84%
2644564643319643942100.17
362589362608662599097.37
462744262775862760097.63
562181862246862214396.78
664002864153964078499.68
2024120621162621162801362711297.5598.192.4895.64%～100.74%
2658904658674658789102.48
362482462320862401697.07
462296662134962215896.78
563938763962363950599.48
661602261533561567895.77
二甲双胍恩格列净片项目信息
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%
19.999792698273979169831898416981700.24
210.069730997237972730.06
单位质量响应值RSD%判断
9826.839669.281.15数据可信
稳定性考察-加速3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
2024120421197857984679816290.6491.051.7889.35%～92.75%
210006110058310032292.63
399039984389873891.17
499318992239927091.66
5100140994109977592.12
695480952849538288.07
2024120521199333989389913691.5392.731.7391.05%～94.41%
210200510144710172693.93
398501983759843890.89
410312010315310313695.23
51005879996410027692.59
6100075997129989492.23
2024120621198111979779804490.5391.460.6490.85%～92.07%
298930983129862191.06
399414988199911691.52
499512991659933891.72
599391992919934191.72
699989997059984792.19
二甲双胍恩格列净片项目信息
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%
110.411074220107405610715511071474107028410723170.17
210.481057380105943110584060.14
单位质量响应值RSD%判断
103008.36100992.941.40数据可信
稳定性考察-加速3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
20241204211114735311449151146134101.14101.220.98100.19%～102.26%
2116119011602871160738102.43
3114835211456311146992101.21
4114809411496851148890101.38
5115347611519321152704101.72
611262281127913112707099.46
20241205211116550411582321161868102.53102.660.74101.87%～103.45%
2117129111666921168992103.16
3115348511482691150877101.56
4117415311781881176170103.79
5116314211601881161665102.51
6116181411597261160770102.43
20241206211114809311495131148803101.37101.660.36101.28%～102.04%
2115411411501471152130101.67
3114898211501941149588101.44
4115443511562171155326101.95
5114847811476981148088101.31
6115872311581311158427102.22
二甲双胍恩格列净片项目信息
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%
19.999771197682979719791197936978420.14
210.069752397485975040.03
单位质量响应值RSD%判断
9793.999692.250.74数据可信
稳定性考察-中间条件3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
2024120421110346310299210322895.3691.812.2189.69%～93.93%
299262986539895891.41
399351996839951791.93
498662980749836890.87
599756995889967292.07
696698964769658789.22
20241205211998261000409993392.3191.791.4690.39%～93.20%
210086010114310100293.30
398413985539848390.97
410061910050710056392.90
599218990919915491.59
697097970769708689.68
20241206211100126998149997092.3591.891.4990.45%～93.32%
298299984329836690.87
397639972699745490.02
410164410145310154893.81
510048410035410041992.76
698812993049905891.51
二甲双胍恩格列净片项目信息
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%
110.415808295802375813105814705823665812420.14
210.485771665766495769080.07
单位质量响应值RSD%判断
55834.9755048.471.01数据可信
稳定性考察-中间条件3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
20241204211647703643126645414104.78101.901.70100.09%～103.72%
2625167621739623453101.21
3632917633695633306102.81
4620385617741619063100.50
5628656628594628625102.05
6616510616265616388100.06
20241205211633558633883633720102.88102.440.68101.71%～103.16%
2636280636636636458103.32
3631442630242630842102.41
4633664631932632798102.73
5627231627043627137101.81
6625242624668624955101.46
20241206211626504623361624932101.45101.900.87100.98%～102.83%
2627412627468627440101.86
3623385620700622042100.98
4638811636861637836103.55
5627705628421628063101.96
6625632626363625998101.63
二甲双胍恩格列净片项目信息
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%
19.999729597288973529723997125972600.09
210.069713097067970980.05
单位质量响应值RSD%判断
9735.749651.890.62数据可信
稳定性考察-中间条件3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
2024120421198206979619808491.0792.041.5390.57%～93.52%
210154310154410154494.28
310036610037510037093.19
499496971869834191.30
598714989939885491.78
697348978719761090.63
2024120521110224610244510234695.0293.341.5391.85%～94.83%
210123610090210106993.84
310067210039810053593.34
410061910003210032693.15
510163010069210116193.92
698152973559775490.76
2024120621110023210047810035593.1793.801.5792.25%～95.34%
210119510064610092093.70
398461980129823691.21
410201410213710207694.77
510230810190810210894.80
610270810220810245895.13
二甲双胍恩格列净片项目信息
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%
110.411059223106188510589841057946105742510590930.17
210.481059815105878510593000.07
单位质量响应值RSD%判断
101738.04101078.240.47数据可信
稳定性考察-中间条件3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
20241204211114111511334061137260100.93102.051.39100.56%～103.54%
2117414811728621173505104.15
3116961811630181166318103.51
4114673711370241141880101.34
5114473611429501143843101.52
6113653711361061136322100.85
20241205211117308611735771173332104.13103.051.02101.95%～104.15%
2117118111697121170446103.88
3115975411551201157437102.72
4116016111596791159920102.94
5116958411609381165261103.42
6114388411371131140498101.22
20241206211116089611691991165048103.40103.421.03102.31%～104.52%
2116794711652061166576103.54
3114516711402501142708101.42
4117754311785781178060104.55
5116745811698331168646103.72
6117359211668511170222103.86
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