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%
110.929367293934936789354293244936140.27
210.979344493135932900.24
单位质量响应值RSD%判断
8572.718504.100.57数据可信
长期6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
20240301211100170100103100136105.55106.941.76104.97%～108.91%
2100350100252100301105.73
3104347104010104178109.81
41000089988999948105.35
5100910101084100997106.46
6103209103104103156108.73
20240302211992369932399280104.65103.621.41102.09%～105.15%
2996339976099696105.09
3967279666896698101.93
4982369863598436103.76
5964839652096502101.72
6992089918799198104.56
20240303211990199927099144104.51105.851.28104.43%～107.27%
2101846101381101614107.11
3100443100407100425105.86
4101503101541101522107.01
5100956101493101224106.70
6985469865398600103.93
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%
19.044784824783214780974786064783974783810.04
29.114838484839294838880.02
单位质量响应值RSD%判断
52918.2553116.140.27数据可信
长期6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
2024030121152509352434552471989.0789.901.3388.66%～91.15%
252338252284852311588.80
354042454015354028891.72
452570252614452592389.28
552709452748852729189.51
653633553639653636691.05
2024030221152642852674552658689.3988.750.7388.08%～89.42%
252593252597252595289.28
351621051616551618887.63
452253652274952264288.72
552152252129752141088.51
652412952407752410388.97
2024030321151776951741451759287.8689.271.0788.27%～90.26%
253109153088253098690.14
352422352425452423888.99
452794152882552838389.70
553133053259153196090.30
652228952172952200988.61
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%
110.921047011048331047701048821046991047770.08
210.971050541050831050680.02
单位质量响应值RSD%判断
9594.969577.760.13数据可信
长期6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
2024030121198696990609887892.8392.342.0590.35%～94.32%
297629978749775291.77
310070710049010059894.44
498508980779829292.28
599983996069979493.69
694868947459480689.01
2024030221110151810129310140695.2094.081.5692.54%～95.62%
299136991929916493.10
310209610195010202395.78
410136210138410137395.17
598837991429899092.94
698306983149831092.30
2024030321110072710042910057894.4393.171.8791.34%～95.00%
210075910070710073394.57
310079110047810063494.48
499025989839900492.95
598576984089849292.47
696182957809598190.11
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%
19.048193858184178182288191938185658187580.07
29.118161158152388156760.08
单位质量响应值RSD%判断
90570.5889536.330.82数据可信
长期6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
2024030121195975295904595939895.8995.351.6493.72%～96.98%
294632394570494601494.55
397094797094297094497.04
495903095867595885295.83
596290296165296227796.17
692702692661592682092.63
2024030221197527197471097499097.4496.561.0895.47%～97.65%
295748395682995715695.66
397420497432397426497.37
497682797482997582897.53
596335596323896329696.28
695100495211695156095.10
2024030321196601996560296581096.5395.851.3594.50%～97.20%
296970996947896959496.91
397152097081497116797.06
495374495347895361195.31
595687295734595710895.66
693674993698293686693.63
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%
110.929355193536939479400693969938020.26
210.979374293735937380.01
单位质量响应值RSD%判断
8589.938544.940.38数据可信
中间条件6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
20240301211100629100654100642105.72106.691.56104.95%～108.43%
2100565100597100581105.66
3103672103710103691108.93
41000149976099887104.93
5101222101282101252106.36
6103209103483103346108.56
20240302211103003102921102962108.16105.471.30104.04%～106.90%
2100416100399100408105.48
3996049975599680104.71
4100192100034100113105.17
5996829978099731104.77
6995779941299494104.52
20240303211985289886798698103.68104.502.25102.04%～106.97%
2101221101105101163106.27
3971009715597128102.03
4101832101734101783106.92
5101358101304101331106.45
6966349695396794101.68
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%
19.044773824770924771964777554777634774380.07
29.114836524839174837840.04
单位质量响应值RSD%判断
52813.9453104.720.39数据可信
中间条件6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
2024030121152339552387952363788.9989.831.1888.73%～90.93%
252427452375852401689.05
353756853727853742391.33
452368752399652384289.02
552792652695152743889.63
653515653527753521690.96
2024030221153853853758253806091.4489.581.1088.55%～90.61%
252305052298752301888.88
352591752587452589689.37
452747152737752742489.63
552658652644252651489.48
652154252203752179088.67
2024030321151661951678651670287.8188.371.5886.91%～89.83%
252928052941452934789.96
351413351475951444687.43
452689452688652689089.54
552427552458852443289.12
650815450834050824786.37
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%
110.921027551027341025341024661024841025950.14
210.971050141048731049440.10
单位质量响应值RSD%判断
9395.159566.451.28数据可信
中间条件6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
202403012119991010026210008695.0293.142.5190.70%～95.59%
298065984289824693.27
310041410031910036695.28
497730976169767392.73
598668987949873193.73
693498936499357488.84
2024030221198874986479876093.7693.691.6192.10%～95.27%
298259983949832693.35
399196993209925894.23
497110970429707692.16
597265972529725892.33
610134810150810142896.29
2024030321199060988399895093.9495.271.9393.35%～97.19%
210040610018010029395.21
310360110340210350298.26
410129010135610132396.19
510001710016510009195.02
697912980009795693.00
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%
19.047965857959447966427968137964987964960.05
29.118098858096338097590.03
单位质量响应值RSD%判断
88107.9688886.830.63数据可信
中间条件6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
2024030121195927595895295911497.5496.471.8294.64%～98.31%
295042695090495066596.68
396483996517496500698.14
494891394870094880696.49
595233395235495234496.85
691583991567891575893.13
2024030221195706695686795696697.3296.941.1495.78%～98.09%
294783294796394789896.40
395709295733095721197.35
494082394154994118695.72
594482994502094492496.10
697133497054697094098.74
2024030321195496795539195517997.1497.931.1196.79%～99.06%
295932195906595919397.55
398267598267598267599.94
496664696662096663398.31
595937595939495938497.57
695436095442595439297.06
点击查看处理图标(人工保存)
　
原始图谱下载图谱(谢鑫慧 于 2025-07-02 16:53:12 完成)
生成报告数据部分(等待生成报告)
Current page cost:85 ms