艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.503812003802473798823803173798333802960.15
2 14.483802153808303805220.12
单位质量响应值RSD%判断
26227.3126279.140.14数据可信
供试品溶液-25110401批-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%
5min1281388-28138873.71068.9412.4373.7168.9412.43
2282917-28291774.11174.11
3240833-24083363.08763.09
4283907-28390774.37074.37
5206078-20607853.98353.98
6284005-28400574.39674.40
10min1340715-34071589.25189.312.2689.3789.432.27
2350574-35057491.83491.96
3329302-32930286.26286.37
4347597-34759791.05491.18
5336124-33612488.04988.14
6341325-34132589.41189.54
15min1355473-35547393.11792.991.1993.3993.251.19
2359113-35911394.07194.35
3348883-34888391.39191.64
4359533-35953394.18194.46
5355351-35535193.08593.32
6351464-35146492.06792.34
20min1351090-35109091.96993.341.2992.4093.761.28
2361215-36121594.62195.05
3351358-35135892.03992.44
4359693-35969394.22394.66
5360113-36011394.33394.72
6354582-35458292.88493.31
30min1351791-35179192.15393.561.3492.7394.131.34
2362489-36248994.95595.55
3353225-35322592.52893.08
4359014-35901494.04594.63
5362425-36242594.93895.49
6354001-35400192.73293.31
45min1351124-35112491.97893.791.4292.7194.521.41
2364876-36487695.58096.33
3355674-35567493.17093.88
4360413-36041394.41195.16
5361426-36142694.67795.38
6354797-35479792.94093.68
60min1350761-35076191.88393.711.3492.7794.601.32
2362369-36236994.92495.83
3356509-35650993.38994.25
4359745-35974594.23695.14
5362781-36278195.03295.90
6354259-35425992.79993.69
极限1349609-34960991.58193.641.4892.6294.681.47
2362525-36252594.96596.03
3359444-35944494.15795.18
4359978-35997894.29795.36
5361115-36111594.59595.62
6352139-35213992.24493.29
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.503790573795043790513794083793583792760.06
2 14.483801403810193805800.17
单位质量响应值RSD%判断
26156.9726283.150.35数据可信
供试品溶液-25110401批-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%
5min1321623-32162384.35784.004.5084.3684.004.51
2316524-31652483.02083.02
3304254-30425479.80179.80
4307842-30784280.74380.74
5327447-32744785.88585.88
6343927-34392790.20790.21
10min1364191-36419195.52294.892.6395.6695.032.63
2352640-35264092.49292.63
3353099-35309992.61392.75
4358155-35815593.93994.07
5364568-36456895.62195.76
6378083-37808399.16699.32
15min1375643-37564398.52696.042.8498.8396.342.84
2353035-35303592.59692.89
3358159-35815993.94094.23
4362127-36212794.98195.27
5368011-36801196.52496.83
6380014-38001499.67299.99
20min1365297-36529795.81295.612.3896.2896.072.39
2353991-35399192.84793.29
3357481-35748193.76294.21
4364258-36425895.54095.99
5367341-36734196.34896.81
6378876-37887699.37499.86
30min1365348-36534895.82695.662.4596.4596.282.45
2352933-35293392.56993.17
3357532-35753293.77694.38
4365329-36532995.82196.43
5368684-36868496.70197.32
6378513-37851399.27999.93
45min1363917-36391795.45095.492.4396.2396.272.43
2353359-35335992.68193.44
3356222-35622293.43294.19
4365722-36572295.92496.69
5366968-36696896.25097.04
6378270-37827099.215100.03
60min1363542-36354295.35295.392.4796.2996.322.48
2351085-35108592.08592.99
3357024-35702493.64294.55
4365278-36527895.80796.74
5368129-36812996.55597.50
6377014-37701498.88599.86
极限1362372-36237295.04595.252.1896.1596.352.19
2352061-35206192.34193.40
3357462-35746293.75794.83
4366269-36626996.06797.16
5365748-36574895.93097.04
6374984-37498498.35399.50
艾托格列净片项目信息
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741-2407001对照品来源原料对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0.41对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.503790633803313794883804453797563798170.16
2 14.483800883793843797360.14
单位质量响应值RSD%判断
26194.2826224.860.09数据可信
供试品溶液-25110401批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1307602-30760280.71179.693.6180.7179.683.61
2319124-31912483.73583.73
3288852-28885275.79275.79
4301174-30117479.02579.02
5295039-29503977.41577.42
6310384-31038481.44181.44
10min1353957-35395792.87491.102.9393.0191.242.93
2351867-35186792.32692.47
3349915-34991591.81491.94
4338168-33816888.73288.86
5331461-33146186.97287.10
6357825-35782593.88994.03
15min1360756-36075694.65893.122.4794.9593.402.47
2355111-35511193.17793.47
3358294-35829494.01294.29
4346081-34608190.80891.09
5343139-34313990.03690.31
6365892-36589296.00696.30
20min1360653-36065394.63193.871.7295.0894.311.72
2356974-35697493.66694.11
3361131-36113194.75795.19
4349617-34961791.73692.17
5352086-35208692.38492.81
6366144-36614496.07296.52
30min1361894-36189494.95794.541.1595.5695.131.15
2355874-35587493.37793.98
3362520-36252095.12195.72
4356009-35600993.41394.00
5359006-35900694.19994.78
6366413-36641396.14396.76
45min1361671-36167194.89994.860.9595.6695.620.94
2356979-35697993.66794.43
3361919-36191994.96495.72
4358545-35854594.07894.82
5363648-36364895.41796.15
6366409-36640996.14296.91
60min1360200-36020094.51394.690.8595.4395.600.85
2356276-35627693.48394.40
3362268-36226895.05595.97
4358802-35880294.14695.04
5362976-36297695.24196.14
6364682-36468295.68996.62
极限1358878-35887894.16694.581.0095.2495.650.99
2355486-35548693.27694.35
3360543-36054394.60395.67
4359171-35917194.24395.30
5362700-36270095.16996.22
6365978-36597896.02997.12
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