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 14.333695493694633696943693893702053696600.09
2 14.473699693698583699140.03
单位质量响应值RSD%判断
25796.2325564.200.64数据可信
供试品溶液-B117113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%
5min1257697-25769769.29671.074.2669.3071.074.26
2266676-26667671.71171.71
3281008-28100875.56575.56
4256785-25678569.05169.05
5250986-25098667.49267.49
6272668-27266873.32273.32
10min1336627-33662790.52188.461.3090.6488.581.30
2329916-32991688.71688.84
3329881-32988188.70788.83
4326101-32610187.69087.81
5325874-32587487.62987.74
6325413-32541387.50587.63
15min1348229-34822993.64191.651.3293.9191.911.32
2341689-34168991.88292.15
3339988-33998891.42591.70
4338117-33811790.92291.18
5342013-34201391.96992.23
6334823-33482390.03690.30
20min1353980-35398095.18792.851.4495.6193.261.43
2345873-34587393.00793.43
3346005-34600593.04393.47
4343276-34327692.30992.72
5343385-34338592.33892.75
6339134-33913491.19591.61
30min1357448-35744896.12094.561.8196.7095.131.80
2360524-36052496.94797.52
3351690-35169094.57195.15
4347117-34711793.34293.91
5349249-34924993.91594.48
6343772-34377292.44293.01
45min1361928-36192897.32595.321.5098.0796.051.49
2358760-35876096.47397.21
3355094-35509495.48796.23
4350557-35055794.26794.99
5352893-35289394.89595.62
6347564-34756493.46294.19
60min1363069-36306997.63195.911.5298.5396.801.52
2359215-35921596.59597.49
3361120-36112097.10798.01
4352140-35214094.69295.57
5355284-35528495.53896.42
6349131-34913193.88394.76
极限1362732-36273297.54195.621.3098.6196.681.30
2358132-35813296.30497.36
3355977-35597795.72496.78
4352101-35210194.68295.72
5355170-35517095.50796.55
6349533-34953393.99195.03
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 14.333695863695613695423697273695383695910.03
2 14.473709043706003707520.06
单位质量响应值RSD%判断
25791.4225622.110.47数据可信
供试品溶液-B111406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%
5min1303196-30319681.44680.371.5081.4580.371.50
2303806-30380681.61081.61
3297150-29715079.82279.82
4302134-30213481.16181.16
5292987-29298778.70478.70
6295848-29584879.47279.47
10min1338289-33828990.87388.712.0091.0188.842.00
2335468-33546890.11590.25
3326106-32610687.60087.73
4333965-33396589.71289.85
5321563-32156386.38086.51
6325996-32599687.57187.70
15min1347501-34750193.34891.311.5593.6391.591.55
2342734-34273492.06792.35
3335072-33507290.00990.29
4341652-34165291.77692.06
5333148-33314889.49289.77
6339319-33931991.15091.43
20min1353006-35300694.82692.141.8995.2792.571.89
2346768-34676893.15193.59
3340065-34006591.35091.78
4344589-34458992.56593.00
5335166-33516690.03490.46
6338333-33833390.88591.32
30min1361002-36100296.97494.471.7297.5895.061.72
2354645-35464595.26795.86
3353279-35327994.90095.48
4350503-35050394.15494.75
5344501-34450192.54293.12
6346198-34619892.99893.58
45min1365394-36539498.15495.821.4998.9296.571.49
2360057-36005796.72097.47
3356503-35650395.76696.51
4354833-35483395.31796.07
5351568-35156894.44095.17
6351897-35189794.52995.27
60min1367386-36738698.68996.021.6999.6296.931.69
2361800-36180097.18998.10
3356056-35605695.64696.54
4354875-35487595.32896.24
5351272-35127294.36195.25
6353376-35337694.92695.82
极限1366729-36672998.51395.961.6999.6097.031.69
2362401-36240197.35098.43
3355667-35566795.54196.60
4354748-35474895.29496.36
5351620-35162094.45495.50
6352292-35229294.63595.69
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 14.333693603695243689953691813696713693460.08
2 14.473688093688233688160.01
单位质量响应值RSD%判断
25774.3225488.320.79数据可信
供试品溶液-Z005796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%
5min1277361-27736174.72771.733.0474.7371.733.04
2260820-26082070.27170.27
3260653-26065370.22670.23
4274588-27458873.98073.98
5266318-26631871.75271.75
6257730-25773069.43869.44
10min1339747-33974791.53588.452.5291.6688.572.52
2325909-32590987.80787.92
3314383-31438384.70284.82
4330241-33024188.97489.10
5330529-33052989.05289.17
6329071-32907188.65988.77
15min1346961-34696193.47990.972.3593.7691.242.35
2336157-33615790.56890.83
3323337-32333787.11487.37
4338243-33824391.13091.40
5341785-34178592.08492.35
6339456-33945691.45791.72
20min1349836-34983694.25392.192.1394.6992.612.13
2340523-34052391.74492.16
3328982-32898288.63589.04
4342558-34255892.29392.72
5347347-34734793.58394.00
6343837-34383792.63793.05
30min1355520-35552095.78594.302.2296.3794.872.22
2348158-34815893.80194.37
3335660-33566090.43490.99
4349796-34979694.24394.82
5356281-35628195.99096.57
6354656-35465695.55296.12
45min1357974-35797496.44695.291.7397.2096.021.73
2352625-35262595.00595.73
3342114-34211492.17392.87
4354019-35401995.38096.11
5357492-35749296.31697.05
6357945-35794596.43897.17
60min1358053-35805396.46795.361.3197.3896.251.32
2352987-35298795.10295.98
3345146-34514692.99093.85
4355998-35599895.91496.81
5354987-35498795.64196.54
6356509-35650996.05196.94
极限1358286-35828696.53095.461.2497.6096.511.25
2352884-35288495.07596.12
3346158-34615893.26294.27
4355830-35583095.86896.92
5356114-35611495.94597.00
6356662-35666296.09297.14
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