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%
19.569580495847956729577495911958020.10
29.609585295782958170.06
单位质量响应值RSD%判断
10021.139980.940.29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
2024030121110256410259710258091.3890.610.8789.79%～91.43%
210099810089910094889.93
310243010241810242491.24
410075010077210076189.76
510107310100910104190.01
610239510265610252691.33
2024030221110200010211210205690.9189.860.8989.03%～90.69%
210006010038310022289.28
310091910079610085889.85
410138310139210138890.32
510109410126510118090.13
699613994639953888.67
2024030321199222992149921888.3987.821.1786.74%～88.89%
299112990319907288.26
397340973409734086.71
4999291000609999489.08
598613989959880488.02
697094970049704986.45
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%
110.394708234709404716264716344713924712830.09
210.414713724715134714420.03
单位质量响应值RSD%判断
45359.2945287.420.12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
20240301211527663528885528274104.90104.000.79103.14%～104.85%
2521394521919521656103.59
3525762525736525749104.40
4518547519659519103103.08
5519666519609519638103.19
6527713527999527856104.82
20240302211526316527172526744104.60104.500.96103.44%～105.55%
2526564527052526808104.61
3527304527391527348104.72
4525386525489525438104.34
5532963533704533334105.91
6517939517320517630102.79
20240303211514566514369514468102.16101.640.70100.90%～102.39%
2513956514960514458102.16
3507951508142508046100.88
4515967516390516178102.50
5509858509755509806101.23
6508126508389508258100.93
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%
19.569925199047989969912999029990900.11
29.609962199451995360.13
单位质量响应值RSD%判断
10365.0610368.330.03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
20240301211100059997539990685.8686.082.2684.04%～88.12%
299741998089977485.75
310323610314210318988.68
496571963949648282.92
510174810181910178487.47
699808998559983285.80
2024030221199266995249939585.4286.121.9384.38%～87.86%
210097810097610097786.78
310169910198110184087.52
4100054995819981885.78
597110968429697683.34
610208810237310223087.86
2024030321110119110118810119086.9686.082.4283.90%～88.27%
210387410385010386289.26
398403981369827084.45
410157310155710156587.28
597976975949778584.04
698372983329835284.52
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%
110.398715358719558714478720628722058718410.04
210.418796928799098798000.02
单位质量响应值RSD%判断
83911.5584514.890.51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
20240301211960699961712961206102.73102.221.37100.76%～103.68%
2951206951506951356101.67
3971422971041971232103.80
4936281935344935812100.01
5967611967941967776103.43
6951387951843951615101.70
20240302211949702949916949809101.51102.151.46100.59%～103.72%
2958747959203958975102.49
3972159972351972255103.91
4951262952807952034101.75
593344693405693375199.79
6968013968348968180103.47
20240303211958205957859958032102.39102.091.88100.08%～104.10%
2981873982603982238104.97
3939086939273939180100.37
4968289969594968942103.55
5936023936413936218100.06
6946947947250947098101.22
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