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-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.333751733754423756683752093744363751860.13
2 14.473765653736453751050.56
单位质量响应值RSD%判断
26181.8625922.940.71数据可信
供试品溶液-2026032321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%
5min1264523-26452370.11672.203.4470.1272.203.44
2258585-25858568.54268.54
3283268-28326875.08575.08
4274857-27485772.85572.86
5280250-28025074.28574.28
6272921-27292172.34272.34
10min1312797-31279782.91286.323.6283.0386.443.61
2309124-30912481.93882.05
3334664-33466488.70888.83
4331730-33173087.93088.05
5336819-33681989.27989.40
6328867-32886787.17187.29
15min1330972-33097287.72990.853.2887.9891.113.28
2326257-32625786.47986.73
3351156-35115693.07993.35
4348321-34832192.32892.60
5352724-35272493.49593.77
6346989-34698991.97592.24
20min1340623-34062390.28793.103.3290.6993.513.32
2332727-33272788.19488.59
3358635-35863595.06295.49
4357826-35782694.84795.27
5361047-36104795.70196.13
6356439-35643994.48094.90
30min1349751-34975192.70795.242.9893.2695.812.98
2342150-34215090.69291.23
3366375-36637597.11397.70
4365286-36528696.82597.40
5367899-36789997.51798.11
6364318-36431896.56897.14
45min1354643-35464394.00496.672.9994.7197.402.99
2347408-34740892.08692.78
3370101-37010198.10198.85
4372679-37267998.78499.53
5372888-37288898.84099.59
6370389-37038998.17798.91
60min1355906-35590694.33896.902.9295.2097.792.92
2348625-34862592.40893.25
3371067-37106798.35799.27
4374124-37412499.167100.07
5373223-37322398.92899.84
6370474-37047498.20099.10
极限1356928-35692894.60997.192.9695.6398.242.96
2349496-34949692.63993.64
3372061-37206198.62099.70
4376201-37620199.718100.79
5374168-37416899.179100.26
6371115-37111598.37099.43
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-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.333745303743133744753741313744673743830.05
2 14.473734923734603734760.01
单位质量响应值RSD%判断
26125.8225810.370.86数据可信
供试品溶液-2026032421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%
5min1272907-27290772.57470.821.5472.5770.821.54
2266767-26676770.94170.94
3269106-26910671.56371.56
4262761-26276169.87669.88
5263427-26342770.05370.05
6262906-26290669.91469.91
10min1326689-32668986.87684.481.5287.0084.601.52
2313629-31362983.40383.52
3319342-31934284.92285.04
4315466-31546683.89284.01
5314871-31487183.73383.85
6316047-31604784.04684.16
15min1344712-34471291.66989.051.6291.9389.311.62
2330248-33024887.82388.08
3336624-33662489.51889.78
4334956-33495689.07589.33
5331110-33111088.05288.31
6331551-33155188.16988.43
20min1351930-35193093.58891.051.5894.0191.461.58
2337325-33732589.70590.11
3343479-34347991.34191.75
4343763-34376391.41791.82
5338199-33819989.93790.34
6339612-33961290.31390.72
30min1356562-35656294.82092.971.4895.3993.531.48
2344071-34407191.49892.05
3351322-35132293.42793.99
4353979-35397994.13394.69
5344431-34443191.59492.15
6347353-34735392.37192.93
45min1359799-35979995.68194.281.4496.4194.991.43
2348873-34887392.77593.48
3355992-35599294.66995.39
4360607-36060795.89696.61
5349532-34953292.95193.66
6352364-35236493.70494.41
60min1361001-36100196.00194.661.6896.8995.541.68
2350996-35099693.34094.20
3357574-35757495.08995.97
4363719-36371996.72397.60
5347991-34799192.54193.40
6354546-35454694.28495.15
极限1360674-36067495.91495.221.5596.9796.251.55
2353335-35333593.96294.98
3360658-36065895.90996.94
4366273-36627397.40398.44
5351268-35126893.41294.43
6356152-35615294.71195.73
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-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4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0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.333730173731563732143730723730263730970.03
2 14.473763203763533763360.01
单位质量响应值RSD%判断
26036.0826008.020.08数据可信
供试品溶液-2026032521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%
5min1280982-28098274.56472.222.8674.5672.222.86
2281257-28125774.63774.64
3267869-26786971.08471.08
4272478-27247872.30772.31
5268557-26855771.26671.27
6261708-26170869.44969.45
10min1324295-32429586.05883.692.4686.1883.812.47
2324502-32450286.11286.24
3311633-31163382.69782.82
4314454-31445483.44683.57
5312656-31265682.96983.09
6304617-30461780.83680.95
15min1337004-33700489.43087.432.1889.7087.692.19
2338205-33820589.74990.02
3326890-32689086.74687.00
4330761-33076187.77388.03
5323429-32342985.82886.08
6320524-32052485.05785.31
20min1343374-34337491.12089.182.0991.5489.582.09
2344010-34401091.28991.71
3335373-33537388.99789.40
4336808-33680889.37889.78
5330388-33038887.67488.07
6326328-32632886.59786.99
30min1351439-35143993.26191.241.9593.8391.801.96
2349782-34978292.82193.39
3344506-34450691.42191.97
4345435-34543591.66792.22
5337020-33702089.43489.98
6334781-33478188.84089.38
45min1356199-35619994.52492.821.7095.2593.531.70
2354863-35486394.16994.89
3352039-35203993.42094.12
4350299-35029992.95893.67
5341947-34194790.74291.44
6343325-34332591.10791.79
60min1358393-35839395.10693.621.6895.9994.491.68
2357270-35727094.80895.69
3357161-35716194.77995.64
4352741-35274193.60694.47
5344574-34457491.43992.29
6346717-34671792.00892.84
极限1359864-35986495.49694.321.7296.5495.341.72
2358095-35809595.02796.07
3363126-36312696.36297.38
4352670-35267093.58794.61
5346325-34632591.90492.90
6352457-35245793.53194.52
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