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DC033-12306002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%
1 10.189415694022939869381493812939580.16
2 10.219409094323942060.18
单位质量响应值RSD%判断
9229.679226.840.03数据可信
供试品溶液-F95653批-恩格列净-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min125302-2530224.42733.5823.6424.4333.5823.64
235141-3514133.92633.93
344409-4440942.87342.87
442917-4291741.43341.43
535570-3557034.34034.34
625370-2537024.49324.49
10min151854-5185450.06167.3820.7950.1067.4320.79
272178-7217869.68269.74
384607-8460781.68181.75
486210-8621083.22983.30
569445-6944567.04367.10
654443-5444352.56052.60
15min173267-7326770.73386.7713.5870.8686.9413.59
295684-9568492.37592.55
3100407-10040796.93597.14
4102267-10226798.73098.94
590778-9077887.63987.81
676876-7687674.21774.35
20min189161-8916186.07794.666.1886.3294.976.21
2102363-10236398.82399.15
3101074-10107497.57897.95
4103690-103690100.104100.48
5100251-10025196.78497.10
691754-9175488.58188.83
30min1102700-10270099.14898.770.7799.5399.240.76
2102508-10250898.96399.45
3101243-10124397.74298.27
4103399-10339999.823100.36
5101567-10156798.05498.53
6102407-10240798.86599.27
45min1103708-103708100.12199.000.90100.6799.630.87
2102569-10256999.02299.68
3101339-10133997.83498.53
4103206-10320699.637100.34
5101592-10159298.07998.72
6102838-10283899.28199.85
60min1103713-103713100.12698.821.21100.8499.621.17
2102870-10287099.312100.13
3100467-10046796.99297.85
4103012-10301299.449100.32
5101225-10122597.72498.53
6102868-10286899.310100.04
极限1104302-104302100.69598.681.31101.5899.641.25
2102140-10214098.60899.59
3100541-10054197.06498.08
4102350-10235098.81099.85
5101086-10108697.59098.56
6102860-10286099.303100.20
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%
110.095360275361215360845363855363775361990.04
210.155388465387725388090.01
单位质量响应值RSD%判断
53141.6353084.630.08数据可信
供试品溶液-F95653批-二甲双胍-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1195064-19506433.05442.5619.4733.0542.5619.48
2253697-25369742.98942.99
3307201-30720152.05552.06
4299354-29935450.72550.73
5257747-25774743.67543.68
6193819-19381932.84332.84
10min1343229-34322958.16073.6217.3858.2273.7017.38
2446523-44652375.66375.73
3512918-51291886.91487.00
4519660-51966088.05688.14
5431459-43145973.11173.18
6353150-35315059.84159.90
15min1452221-45222176.62989.4910.7376.7889.6910.74
2557293-55729394.43394.63
3574663-57466397.37697.61
4585404-58540499.19799.43
5533949-53394990.47790.67
6465274-46527478.84179.00
20min1527733-52773389.42495.514.4489.7095.864.48
2581002-58100298.45198.81
3575845-57584597.57797.97
4585090-58509099.14399.54
5576384-57638497.66898.01
6536005-53600590.82691.11
30min1588975-58897599.80298.520.76100.2399.020.74
2580137-58013798.30498.82
3577411-57741197.84298.40
4584269-58426999.00499.57
5578925-57892598.09998.61
6578774-57877498.07398.51
45min1590626-590626100.08198.400.93100.6899.070.90
2578499-57849998.02698.71
3576216-57621697.64098.36
4582687-58268798.73699.46
5576688-57668897.72098.39
6579587-57958798.21198.81
60min1589556-58955699.90098.311.14100.6699.141.11
2584371-58437199.02199.87
3571098-57109896.77297.65
4582001-58200198.62099.51
5575190-57519097.46698.30
6578895-57889598.09498.86
极限1588371-58837199.69997.941.07100.6398.931.03
2577277-57727797.81998.83
3569912-56991296.57197.62
4580235-58023598.32199.38
5574635-57463597.37298.37
6577360-57736097.83398.76
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DC033-12306002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%
1 10.189380694033941379402994231940470.17
2 10.219399294092940420.08
单位质量响应值RSD%判断
9238.419210.770.22数据可信
供试品溶液-F95653批-恩格列净-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133093-3309331.96135.389.8631.9635.389.87
239383-3938338.03638.04
337402-3740236.12336.12
431511-3151130.43330.43
540791-4079139.39639.40
637643-3764336.35636.36
10min169603-6960367.22369.847.0567.2869.907.05
274670-7467072.11672.18
373252-7325270.74770.81
463375-6337561.20861.26
577282-7728274.63974.70
675694-7569473.10573.17
15min194511-9451191.27990.975.2991.4491.155.29
296110-9611092.82393.01
394345-9434591.11991.30
484534-8453481.64381.80
597374-9737494.04494.23
698290-9829094.92995.11
20min1102064-10206498.57497.042.0198.8997.372.02
2102114-10211498.62298.96
3101214-10121497.75398.08
496712-9671293.40593.69
5100002-10000296.58296.93
6100755-10075597.30997.65
30min1102289-10228998.79197.980.9899.2798.470.97
2102412-10241298.91099.41
3101689-10168998.21198.70
4101766-10176698.28698.73
599867-9986796.45296.96
6100666-10066697.22397.73
45min1102168-10216898.67497.960.9099.3298.610.89
2102530-10253099.02499.69
3101219-10121997.75798.41
4101443-10144397.97498.58
599908-9990896.49197.16
6101316-10131697.85198.52
60min1102267-10226798.77097.861.0399.5898.671.02
2102027-10202798.53899.37
3101740-10174098.26199.08
4100900-10090097.44998.22
599425-9942596.02596.85
6101569-10156998.09598.92
极限1101690-10169098.21297.300.9599.1998.280.94
2101675-10167598.19899.19
3101004-10100497.55098.53
4100759-10075997.31398.25
599210-9921095.81796.81
6100150-10015096.72597.72
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%
110.095367275370905370385370245374055370570.05
210.155376315380045378180.05
单位质量响应值RSD%判断
53226.6652987.000.32数据可信
供试品溶液-F95653批-二甲双胍-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1243492-24349241.26544.748.5541.2644.748.55
2279317-27931747.33647.34
3269647-26964745.69745.70
4231647-23164739.25739.26
5292269-29226949.53149.53
6267611-26761145.35245.35
10min1434822-43482273.69076.326.4373.7676.406.43
2461028-46102878.13178.21
3457811-45781177.58677.66
4400554-40055467.88267.95
5483423-48342381.92682.01
6464516-46451678.72278.80
15min1552900-55290093.70093.854.7193.8994.054.72
2560982-56098295.07095.28
3554731-55473194.01194.22
4504273-50427385.45985.64
5576244-57624497.65697.88
6573551-57355197.20097.41
20min1578877-57887798.10397.631.4498.4597.981.45
2581542-58154298.55498.92
3581752-58175298.59098.95
4560948-56094895.06495.39
5581139-58113998.48698.87
6572124-57212496.95897.33
30min1578808-57880898.09198.020.6498.6098.540.64
2581719-58171998.58499.12
3581884-58188498.61299.14
4576361-57636197.67698.16
5579467-57946798.20398.75
6572189-57218996.96997.50
45min1577774-57777497.91697.910.4798.5998.600.47
2580127-58012798.31499.01
3579553-57955398.21798.91
4575698-57569897.56498.21
5579876-57987698.27298.98
6573521-57352197.19597.89
60min1578047-57804797.96298.230.8298.8099.080.83
2579245-57924598.16599.02
3587657-58765799.591100.45
4573682-57368297.22298.03
5577513-57751397.87198.74
6581786-58178698.59699.45
极限1575898-57589897.59897.390.6798.6098.400.66
2577580-57758097.88398.91
3577408-57740897.85498.87
4573328-57332897.16298.13
5576123-57612397.63698.67
6567563-56756396.18597.20
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