氨溴酸替格列汀片项目信息
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%
114.606818286814316813806817896810156814890.05
214.706785566788686787120.04
单位质量响应值RSD%判断
46677.3346170.880.78数据可信
供试品溶液-G031批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1214226-21422626.77828.032.9726.7828.032.97
2228472-22847228.55928.56
3225224-22522428.15328.15
4218419-21841927.30227.30
5227032-22703228.37928.38
6231972-23197228.99629.00
10min1456279-45627957.03455.584.0657.0855.634.05
2464241-46424158.02958.08
3417614-41761452.20152.25
4444629-44462955.57855.62
5429115-42911553.63953.69
6456123-45612357.01557.06
15min1608736-60873676.09175.452.4276.2375.592.42
2615005-61500576.87577.02
3582061-58206172.75772.89
4602543-60254375.31775.45
5591997-59199773.99974.14
6621182-62118277.64777.79
20min1721475-72147590.18390.031.6890.4590.291.69
2731924-73192491.48991.76
3699680-69968087.45987.71
4722048-72204890.25590.52
5714472-71447289.30889.57
6731792-73179291.47391.75
30min1794471-79447199.308100.240.6799.72100.660.67
2802320-802320100.289100.71
3802036-802036100.253100.65
4806617-806617100.826101.24
5797501-79750199.686100.10
6808722-808722101.089101.51
45min1794256-79425699.281100.070.7299.86100.660.72
2796019-79601999.501100.09
3801439-801439100.179100.75
4807080-807080100.884101.47
5797160-79716099.644100.22
6807651-807651100.955101.55
极限1791462-79146298.93199.970.7399.68100.720.73
2797768-79776899.720100.48
3799278-79927899.908100.64
4805862-805862100.731101.48
5797295-79729599.661100.40
6807043-807043100.879101.64
氨溴酸替格列汀片项目信息
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%
114.603408693409453414973419263411693412810.13
214.703413853408643411240.11
单位质量响应值RSD%判断
23375.4123205.710.52数据可信
供试品溶液-G246批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1130928-13092832.62133.7510.0932.6233.7510.09
2123459-12345930.76030.76
3124560-12456031.03431.03
4154404-15440438.47038.47
5128428-12842831.99832.00
6150978-15097837.61637.62
10min1239083-23908359.56763.784.5659.6263.844.56
2252086-25208662.80762.86
3248090-24809061.81261.86
4266985-26698566.51966.58
5269213-26921367.07467.13
6260498-26049864.90364.97
15min1337877-33787784.18286.571.8184.3486.741.81
2343899-34389985.68285.84
3347946-34794686.69186.85
4352902-35290287.92588.10
5355284-35528488.51988.68
6346883-34688386.42686.60
20min1389225-38922596.97598.500.9797.2798.810.97
2394811-39481198.36798.67
3394833-39483398.37398.67
4400153-40015399.698100.02
5398574-39857499.30599.62
6394518-39451898.29498.61
30min1403779-403779100.601101.110.64101.06101.580.63
2406830-406830101.362101.82
3408304-408304101.729102.19
4408128-408128101.685102.17
5401835-401835100.117100.60
6406163-406163101.195101.67
45min1402638-402638100.317101.080.56100.94101.720.56
2406285-406285101.226101.86
3407268-407268101.471102.10
4408175-408175101.697102.35
5403186-403186100.454101.10
6406613-406613101.308101.95
极限1401507-401507100.035100.680.72100.83101.490.72
2405592-405592101.053101.85
3407184-407184101.450102.25
4406920-406920101.384102.21
5400358-40035899.749100.56
6402990-402990100.405101.22
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