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%
110.189407493711937099387393435937600.26
210.219429694075941860.17
单位质量响应值RSD%判断
9210.229224.880.12数据可信
供试品溶液-F95653批-恩格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129239-2923928.26133.1710.7628.2633.1710.76
234190-3419033.04633.05
336829-3682935.59735.60
439078-3907837.77037.77
530922-3092229.88729.89
635663-3566334.47034.47
10min160670-6067058.64068.808.8558.6968.858.85
269670-6967067.33967.39
374360-7436071.87271.93
477637-7763775.03975.10
568420-6842066.13166.18
676302-7630273.74973.81
15min183053-8305380.27491.696.6980.4291.866.70
293381-9338190.25690.42
399538-9953896.20796.39
499243-9924395.92296.11
594776-9477691.60591.76
699181-9918195.86296.04
20min196699-9669993.46398.922.7893.7499.242.80
2102716-10271699.27999.60
3104655-104655101.153101.49
4103115-10311599.665100.01
5103661-103661100.192100.50
6103223-10322399.769100.11
30min1103440-10344099.979100.150.75100.41100.640.74
2103330-10333099.872100.36
3104988-104988101.475101.98
4102974-10297499.528100.04
5104009-104009100.529101.01
6102988-10298899.542100.05
45min1103495-103495100.032100.130.70100.63100.780.70
2103376-10337699.917100.57
3104884-104884101.374102.05
4102962-10296299.517100.20
5103881-103881100.405101.05
6102966-10296699.521100.19
60min1103541-103541100.076100.180.78100.84101.000.77
2103159-10315999.707100.52
3104630-104630101.129101.97
4102897-10289799.454100.30
5104671-104671101.168101.98
6103017-10301799.570100.41
极限1103554-103554100.089100.030.60101.02101.020.59
2103434-10343499.973100.96
3104506-104506101.009102.02
4102852-10285299.410100.42
5103736-103736100.265101.25
6102863-10286399.421100.43
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%
110.095954815942835943025942845930105942720.15
210.155961855965765963800.05
单位质量响应值RSD%判断
58897.1358756.650.17数据可信
供试品溶液-F95653批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1240571-24057136.80541.478.5836.8141.478.57
2267919-26791940.98940.99
3285744-28574443.71643.72
4301529-30152946.13146.13
5248723-24872338.05338.05
6281844-28184443.12043.12
10min1413704-41370463.29371.667.2863.3571.727.28
2457812-45781270.04170.11
3484591-48459174.13874.21
4503759-50375977.07177.15
5451728-45172869.11169.17
6498600-49860076.28276.35
15min1527420-52742080.69189.035.1280.8689.225.12
2574639-57463987.91588.10
3603367-60336792.31092.51
4604773-60477392.52592.73
5579241-57924188.61988.80
6602201-60220192.13292.33
20min1592154-59215490.59593.391.5290.9093.731.54
2612825-61282593.75794.09
3618790-61879094.67095.02
4613022-61302293.78794.15
5612089-61208993.64493.97
6613637-61363793.88194.23
30min1616206-61620694.27494.020.4594.7394.510.44
2613444-61344493.85294.34
3619229-61922994.73795.24
4613713-61371393.89394.41
5612214-61221493.66494.15
6612337-61233793.68294.19
45min1616541-61654194.32693.870.4794.9394.520.46
2613045-61304593.79194.43
3617408-61740894.45895.12
4612935-61293593.77494.45
5610371-61037193.38294.02
6611100-61110093.49394.16
60min1615958-61595894.23693.940.3995.0094.750.37
2613203-61320393.81594.62
3616749-61674994.35795.18
4611013-61101393.48094.31
5615461-61546194.16094.95
6611824-61182493.60494.42
极限1616173-61617394.26993.760.4695.1994.720.45
2612931-61293193.77394.73
3616233-61623394.27895.26
4610361-61036193.38094.36
5610417-61041793.38994.34
6610821-61082193.45094.43
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%
110.189410893993940299413494179940890.09
210.219418994276942320.07
单位质量响应值RSD%判断
9242.539229.380.11数据可信
供试品溶液-F95653批-恩格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133506-3350632.32033.868.2732.3233.868.27
234659-3465933.43233.43
336404-3640435.11635.12
430543-3054329.46229.46
538954-3895437.57537.58
636517-3651735.22535.22
10min168975-6897566.53468.267.7666.5968.327.76
268892-6889266.45466.51
372855-7285570.27770.34
462366-6236660.15960.21
578853-7885376.06276.13
672621-7262170.05170.11
15min192441-9244189.17089.425.4589.3389.585.45
290950-9095087.73187.90
394327-9432790.98991.16
484378-8437881.39281.54
599731-9973196.20296.39
694347-9434791.00891.18
20min1101264-10126497.68097.621.6997.9997.941.71
2100957-10095797.38497.70
3102342-10234298.72099.05
497942-9794294.47694.76
5102472-10247298.84699.20
6102210-10221098.59398.92
30min1101641-10164198.04498.810.5298.5299.290.52
2102285-10228598.66599.14
3103273-10327399.618100.11
4102483-10248398.85699.30
5102405-10240598.78199.30
6102530-10253098.90299.39
45min1101494-10149497.90298.870.6498.5499.520.65
2101996-10199698.38699.03
3103343-10334399.686100.34
4102658-10265899.02599.63
5102815-10281599.17699.86
6102693-10269399.05999.72
60min1101615-10161598.01998.580.8898.8299.400.87
2101766-10176698.16598.97
3103330-10333099.673100.50
4103158-10315899.507100.28
5102279-10227998.65999.50
6101059-10105997.48398.30
极限1101710-10171098.11198.500.7499.0899.480.73
2101660-10166098.06299.03
3103046-10304699.399100.39
4102726-10272699.091100.03
5102449-10244998.82399.83
6101084-10108497.50798.49
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%
110.095960445958295955525952065963015957860.08
210.155974205982035978120.10
单位质量响应值RSD%判断
59047.1858897.730.18数据可信
供试品溶液-F95653批-二甲双胍-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1265816-26581640.56742.406.3740.5742.406.37
2273261-27326141.70341.70
3283623-28362343.28543.28
4252865-25286538.59138.59
5302858-30285846.22046.22
6288554-28855444.03744.04
10min1459077-45907770.06271.796.3070.1371.866.30
2457583-45758369.83469.90
3479091-47909173.11673.19
4427010-42701065.16865.23
5514052-51405278.45178.53
6485476-48547674.09074.16
15min1574077-57407787.61287.884.2687.8088.074.26
2565094-56509486.24186.43
3581360-58136088.72488.92
4536548-53654881.88582.06
5609932-60993293.08493.29
6588021-58802189.74089.94
20min1609543-60954393.02593.191.1093.3693.521.11
2608105-60810592.80593.13
3612277-61227793.44293.78
4599541-59954191.49891.81
5615379-61537993.91594.28
6618749-61874994.43094.78
30min1608715-60871592.89893.630.5093.3894.120.50
2611994-61199493.39993.88
3613717-61371793.66294.16
4615811-61581193.98194.44
5613322-61332293.60194.12
6617502-61750294.23994.74
45min1606546-60654692.56793.630.7493.2194.280.74
2609522-60952293.02293.66
3614715-61471593.81494.47
4616470-61647094.08294.70
5615671-61567193.96094.64
6618222-61822294.34995.01
60min1607201-60720192.66793.300.5593.4694.100.55
2608568-60856892.87693.67
3613961-61396193.69994.51
4615797-61579793.97994.75
5612705-61270593.50794.34
6609685-60968593.04693.86
极限1606826-60682692.61093.160.5993.5694.120.59
2606166-60616692.50993.46
3611133-61113393.26794.23
4614196-61419693.73594.67
5614685-61468593.80994.80
6609709-60970993.05094.02
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