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(%)98.99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%
110.699580495847956729577495911958020.10
210.729585295782958170.06
单位质量响应值RSD%判断
8961.838938.150.19数据可信
加速1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
20240301211102564102597102580102.11101.250.87100.33%～102.17%
2100998100899100948100.49
3102430102418102424101.96
4100750100772100761100.30
5101073101009101041100.58
6102395102656102526102.06
20240302211102000102112102056101.59100.410.8999.48%～101.34%
210006010038310022299.76
3100919100796100858100.40
4101383101392101388100.92
5101094101265101180100.72
699613994639953899.08
2024030321199222992149921898.7698.131.1796.93%～99.33%
299112990319907298.62
397340973409734096.90
4999291000609999499.54
598613989959880498.35
697094970049704996.61
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%
19.864708234709404716264716344713924712830.09
29.904713724715134714420.03
单位质量响应值RSD%判断
47797.4647620.400.27数据可信
加速1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
2024030121152766352888552827499.6698.800.7997.99%～99.61%
252139452191952165698.41
352576252573652574999.18
451854751965951910397.93
551966651960951963898.03
652771352799952785699.58
2024030221152631652717252674499.3799.270.9698.27%～100.27%
252656452705252680899.38
352730452739152734899.48
452538652548952543899.12
5532963533704533334100.61
651793951732051763097.65
2024030321151456651436951446897.0588.6022.4067.78%～109.42%
251395651496051445897.05
350795150814250804695.84
451596751639051617897.37
550985850975550980696.17
6508126202125507448.12
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(%)98.99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%
110.699925199047989969912999029990900.11
210.729962199451995360.13
单位质量响应值RSD%判断
9269.419285.070.12数据可信
加速1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
20240301211100059997539990695.9496.182.2793.90%～98.47%
299741998089977495.81
310323610314210318999.09
496571963949648292.65
510174810181910178497.75
699808998559983295.87
2024030221199266995249939595.4596.231.9394.29%～98.17%
210097810097610097796.97
310169910198110184097.80
4100054995819981895.86
597110968429697693.13
610208810237310223098.17
2024030321110119110118810119097.1796.192.4293.76%～98.63%
210387410385010386299.74
398403981369827094.37
410157310155710156597.53
597976975949778593.90
698372983329835294.45
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%
19.868715358719558714478720628722058718410.04
29.908796928799098798000.02
单位质量响应值RSD%判断
88422.0188868.690.36数据可信
加速1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
2024030121196069996171296120697.5997.111.3795.73%～98.50%
295120695150695135696.59
397142297104197123298.61
493628193534493581295.01
596761196794196777698.26
695138795184395161596.62
2024030221194970294991694980996.4397.041.4695.56%～98.53%
295874795920395897597.36
397215997235197225598.71
495126295280795203496.66
593344693405693375194.80
696801396834896818098.30
2024030321195820595785995803297.2796.991.8995.07%～98.91%
298187398260398223899.73
393908693927393918095.35
496828996959496894298.38
593602393641393621895.05
694694794725094709896.16
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