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(%)0.41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%
114.273698523697603697223699303700413698610.04
214.323693693697053695370.07
单位质量响应值RSD%判断
25918.7825805.660.31数据可信
供试品溶液-2026032321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%
5min1273159-27315972.63770.572.6872.6470.572.68
2268820-26882071.48371.48
3257842-25784268.56468.56
4268017-26801771.27071.27
5255273-25527367.88167.88
6269164-26916471.57571.57
10min1329194-32919487.53786.372.5987.6686.492.59
2322451-32245185.74485.86
3313912-31391283.47483.59
4338502-33850290.01390.13
5320231-32023185.15485.27
6324541-32454186.30086.42
15min1346804-34680492.22091.492.6992.4991.752.69
2339095-33909590.17090.43
3332479-33247988.41188.66
4360056-36005695.74496.01
5342016-34201690.94791.20
6343915-34391591.45291.72
20min1354837-35483794.35693.542.8294.7893.962.82
2345351-34535191.83492.25
3340553-34055390.55890.96
4368945-36894598.10898.54
5347629-34762992.44092.85
6353276-35327693.94194.36
30min1364288-36428896.86995.682.6097.4596.252.60
2349046-34904692.81693.38
3354596-35459694.29294.84
4374601-37460199.612100.20
5353243-35324393.93294.49
6363189-36318996.57797.15
45min1372992-37299299.18496.873.0499.9297.603.03
2357341-35734195.02295.74
3351183-35118393.38594.09
4377062-377062100.266101.02
5354917-35491794.37895.09
6372201-37220198.97499.71
60min1378122-378122100.54897.033.75101.4597.923.74
2350382-35038293.17294.05
3352356-35235693.69794.56
4376901-376901100.223101.15
5354692-35469294.31895.19
6376872-376872100.216101.11
极限1394318-394318104.85597.855.05105.9398.905.02
2349296-34929692.88393.92
3352205-35220593.65694.68
4375710-37571099.907101.00
5354508-35450894.26995.30
6381729-381729101.507102.57
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(%)0.41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%
114.273693463696563695383693713696163695050.04
214.323696313701863699080.11
单位质量响应值RSD%判断
25893.8325831.560.18数据可信
供试品溶液-2026032321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%
5min1266298-26629870.81169.473.6370.8169.473.63
2263959-26395970.18970.19
3275315-27531573.20973.21
4258294-25829468.68368.68
5247806-24780665.89465.89
6255875-25587568.03968.04
10min1335837-33583789.30286.133.4989.4286.253.49
2320657-32065785.26585.38
3340394-34039490.51490.64
4316487-31648784.15784.27
5314142-31414283.53383.64
6316013-31601384.03184.14
15min1359644-35964495.63291.733.7095.9091.993.70
2338943-33894390.12890.39
3362932-36293296.50796.78
4335609-33560989.24189.50
5336755-33675589.54689.80
6335909-33590989.32189.57
20min1366352-36635297.41694.063.4197.8494.473.40
2346952-34695292.25892.67
3371219-37121998.71099.14
4343895-34389591.44591.85
5350457-35045793.19093.59
6343487-34348791.33691.74
30min1372698-37269899.10495.913.3899.6996.483.38
2359260-35926095.53096.09
3378618-378618100.678101.28
4351903-35190393.57494.13
5352268-35226893.67194.22
6349447-34944792.92193.48
45min1375320-37532099.80196.973.18100.5597.703.18
2363895-36389596.76397.49
3381897-381897101.550102.32
4358457-35845795.31796.03
5355202-35520294.45195.16
6353261-35326193.93594.64
60min1375481-37548199.84497.313.06100.7698.203.06
2368058-36805897.87098.75
3382008-382008101.579102.51
4359907-35990795.70296.57
5354860-35486094.36095.23
6355413-35541394.50795.37
极限1374449-37444999.56997.542.97100.6698.592.97
2367860-36786097.81798.86
3381621-381621101.476102.58
4368206-36820697.90998.94
5354514-35451494.26895.29
6354232-35423294.19395.22
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(%)0.41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%
114.273702093705223707283704583704233704680.06
214.323683583684913684240.03
单位质量响应值RSD%判断
25961.3225727.930.64数据可信
供试品溶液-2026032321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%
5min1260246-26024669.25168.693.6069.2568.693.60
2263524-26352470.12470.12
3255260-25526067.92567.92
4262892-26289269.95569.96
5240768-24076864.06864.07
6266187-26618770.83270.83
10min1323132-32313285.98584.732.8886.1084.852.88
2328335-32833587.37087.49
3308989-30898982.22282.34
4325716-32571686.67386.79
5305879-30587981.39481.50
6318529-31852984.76084.88
15min1344637-34463791.70890.302.7491.9790.552.74
2350303-35030393.21693.48
3328738-32873887.47787.73
4346789-34678992.28092.54
5329052-32905287.56187.80
6336460-33646089.53289.79
20min1357317-35731795.08292.762.8295.4993.172.82
2357976-35797695.25795.68
3337592-33759289.83390.23
4355779-35577994.67395.09
5336920-33692089.65490.04
6345963-34596392.06192.47
30min1362634-36263496.49794.582.6597.0795.142.65
2365498-36549897.25997.84
3345549-34554991.95092.50
4363306-36330696.67697.25
5345365-34536591.90292.44
6350260-35026093.20493.77
45min1367779-36777997.86696.072.6398.6096.792.63
2371474-37147498.84999.59
3353596-35359694.09294.79
4369275-36927598.26499.00
5350067-35006793.15393.84
6353972-35397294.19294.91
60min1371317-37131798.80796.552.9499.7097.422.93
2374483-37448399.650100.55
3354522-35452294.33895.19
4371537-37153798.86699.76
5353794-35379494.14494.99
6351333-35133393.49094.36
极限1376366-376366100.15197.563.10101.2198.603.09
2378832-378832100.807101.88
3360451-36045195.91696.93
4374658-37465899.696100.76
5357455-35745595.11996.12
6352024-35202493.67394.70
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(%)0.41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%
114.273678943680013679783680523680833680020.02
214.323692883694473693680.04
单位质量响应值RSD%判断
25788.5125793.850.02数据可信
供试品溶液-2026032321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%
5min1268553-26855371.60869.622.5871.6169.622.58
2258771-25877169.00069.00
3260356-26035669.42369.42
4249655-24965566.56966.57
5266784-26678471.13771.14
6262365-26236569.95869.96
10min1334111-33411189.08986.972.2489.2187.092.24
2324309-32430986.47686.59
3323051-32305186.14086.26
4314413-31441383.83783.95
5333167-33316788.83888.96
6327977-32797787.45487.57
15min1353522-35352294.26592.132.7094.5392.392.70
2349308-34930893.14193.40
3344474-34447491.85292.11
4328919-32891987.70587.96
5353985-35398594.38994.66
6342832-34283291.41591.68
20min1361642-36164296.43094.362.5396.8694.772.53
2353208-35320894.18194.60
3357999-35799995.45995.87
4337275-33727589.93390.33
5360461-36046196.11596.54
6352576-35257694.01394.43
30min1367600-36760098.01996.062.3398.6096.632.33
2360904-36090496.23396.80
3362439-36243996.64397.21
4344788-34478891.93692.48
5367209-36720997.91598.50
6358602-35860295.62096.19
45min1373917-37391799.70397.672.52100.4598.402.52
2367945-36794598.11198.84
3368019-36801998.13198.86
4349025-34902593.06693.77
5374098-37409899.752100.50
6364788-36478897.26998.00
60min1377933-377933100.77498.542.80101.6999.442.79
2371469-37146999.05199.95
3371471-37147199.05199.95
4351309-35130993.67594.53
5379786-379786101.268102.18
6365414-36541497.43698.33
极限1379835-379835101.28199.532.57102.36100.592.57
2377117-377117100.557101.62
3377837-377837100.749101.81
4354023-35402394.39995.41
5376286-376286100.335101.42
6374575-37457599.879100.93
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