氨溴酸替格列净片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.776775546779896777036779356774526777270.04
214.796773386768836771100.05
单位质量响应值RSD%判断
45885.3845781.610.17数据可信
供试品溶液-2024090521-gw1M-bc1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%
5min1180500-18050022.85221.416.6522.8521.416.64
2148778-14877818.83618.84
3164992-16499220.88920.89
4171786-17178621.74921.75
5172072-17207221.78521.79
6176532-17653222.35022.35
10min1343934-34393443.54441.636.8543.5841.676.85
2285654-28565436.16536.20
3327542-32754241.46941.50
4343035-34303543.43043.47
5328592-32859241.60241.64
6344306-34430643.59143.63
15min1462253-46225358.52456.207.2258.6356.317.22
2381769-38176948.33448.43
3441135-44113555.85055.95
4466722-46672259.09059.20
5447941-44794156.71256.82
6463698-46369858.70758.82
20min1558648-55864870.72868.157.2470.9468.347.24
2462492-46249258.55458.73
3534448-53444867.66467.86
4566792-56679271.75971.97
5545269-54526969.03469.23
6561843-56184371.13271.34
30min1705666-70566689.34185.756.4489.6786.066.44
2593724-59372475.16975.44
3670886-67088684.93885.25
4710757-71075789.98690.31
5682835-68283586.45186.77
6699908-69990888.61288.94
45min1771048-77104897.61994.132.7398.0994.592.75
2714848-71484890.50490.90
3729076-72907692.30592.76
4759931-75993196.21196.69
5742904-74290494.05694.51
6743187-74318794.09294.57
极限1803713-803713101.75498.352.31102.3998.962.30
2784106-78410699.27299.82
3759129-75912996.11096.72
4788033-78803399.769100.41
5764894-76489496.84097.46
6761089-76108996.35896.99
氨溴酸替格列净片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.776779486772316775306774356773726775030.05
214.796777946774806776370.04
单位质量响应值RSD%判断
45870.2145817.240.09数据可信
供试品溶液-2024090521-gw1M-bc2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%
5min1118796-11879615.03716.555.5015.0416.545.49
2138034-13803417.47217.47
3130456-13045616.51316.51
4138215-13821517.49517.49
5128215-12821516.22916.23
6130566-13056616.52716.53
10min1240961-24096130.50032.444.8530.5332.474.84
2252859-25285932.00632.04
3256242-25624232.43432.46
4246697-24669731.22631.26
5266885-26688533.78233.81
6274189-27418934.70634.73
15min1329614-32961441.72243.524.7441.8043.604.73
2337697-33769742.74542.83
3342916-34291643.40543.49
4327382-32738241.43941.52
5355597-35559745.01045.09
6369791-36979146.80746.89
20min1399275-39927550.53952.494.5750.6852.644.57
2407865-40786551.62651.78
3410063-41006351.90552.06
4396746-39674650.21950.37
5427969-42796954.17154.33
6446087-44608756.46456.63
30min1513390-51339064.98366.873.8565.2167.113.85
2522670-52267066.15866.40
3521598-52159866.02266.26
4508297-50829764.33964.57
5540947-54094768.47168.72
6563015-56301571.26571.52
45min1642901-64290181.37782.722.4681.7183.082.46
2651693-65169382.48982.84
3650950-65095082.39582.75
4638788-63878880.85681.20
5652761-65276182.62582.99
6684206-68420686.60586.98
极限1773311-77331197.88398.070.7898.3698.560.77
2768648-76864897.29397.78
3770613-77061397.54298.03
4782602-78260299.05999.54
5781865-78186598.96699.47
6771513-77151397.65698.18
氨溴酸替格列净片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.776782956782666778706781706776496780500.05
214.796760576764646762600.05
单位质量响应值RSD%判断
45907.2445724.140.29数据可信
供试品溶液-2024090521-gw1M-bc3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%
5min1115872-11587214.67614.2418.5714.6814.2418.56
2122355-12235515.49715.50
3121423-12142315.37915.38
470417-704178.9198.92
5118691-11869115.03315.03
6125972-12597215.95515.95
10min1232594-23259429.45928.2712.0729.4828.3012.08
2235756-23575629.86029.89
3231417-23141729.31029.34
4168406-16840621.32921.34
5236037-23603729.89529.92
6235213-23521329.79129.82
15min1310298-31029839.30138.0811.2539.3738.1511.25
2312337-31233739.55939.63
3311777-31177739.48839.56
4232044-23204429.39029.44
5318480-31848040.33740.41
6318965-31896540.39940.47
20min1374541-37454147.43745.8810.8347.5846.0210.84
2375940-37594047.61547.76
3369387-36938746.78546.92
4283224-28322435.87235.97
5384537-38453748.70448.85
6386019-38601948.89149.03
30min1478594-47859460.61658.5610.8360.8358.7810.84
2477788-47778860.51460.74
3471576-47157659.72759.95
4361668-36166845.80745.97
5489729-48972962.02762.25
6494944-49494462.68762.91
45min1593752-59375275.20272.8111.1675.5273.1211.17
2592752-59275275.07575.40
3585925-58592574.21074.53
4446619-44661956.56756.80
5609163-60916377.15477.48
6621183-62118378.67679.01
极限1777044-77704498.41695.506.0998.8695.936.12
2778064-77806498.54698.99
3761521-76152196.45096.89
4662777-66277783.94484.27
5758621-75862196.08396.54
6786077-78607799.561100.02
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