贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.239770669723379722599725729760429740550.24
211.299735749758079746900.17
单位质量响应值RSD%判断
86736.8786332.150.34数据可信
供试品溶液-2024092721批-依折麦布-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min136956-369563.8344.4817.343.834.4817.36
237641-376413.9053.91
357417-574175.9575.96
441041-410414.2584.26
544090-440904.5744.57
641715-417154.3284.33
10min168761-687617.1347.473.007.187.523.02
271276-712767.3957.44
372649-726497.5377.60
471293-712937.3967.44
575280-752807.8107.86
672788-727887.5517.60
15min176234-762347.9097.823.008.037.952.91
278746-787468.1708.30
373068-730687.5807.73
472723-727237.5457.67
575013-750137.7827.92
676277-762777.9138.05
20min181572-815728.4638.221.638.678.441.53
279443-794438.2428.46
378336-783368.1278.36
478160-781608.1098.32
578348-783488.1288.35
679383-793838.2368.46
30min178987-789878.1957.853.048.508.162.93
274900-749007.7718.08
377713-777138.0628.39
475552-755527.8388.14
572744-727447.5477.86
674257-742577.7048.02
45min182748-827488.5858.028.188.988.427.85
271650-716507.4337.83
387397-873979.0679.48
474845-748457.7658.16
572965-729657.5707.97
673945-739457.6718.07
60min1109533-10953311.3649.2116.2111.859.7015.48
269755-697557.2377.71
399188-9918810.29010.81
482213-822138.5299.01
579863-798638.2858.77
691963-919639.54110.02
极限1136709-13670914.18313.4631.8814.8014.0530.66
269530-695307.2137.77
3148246-14824615.38016.01
4111856-11185611.60512.18
5118533-11853312.29712.87
6193729-19372920.09820.69
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.922515582503732509522510962517102511380.22
29.932510062504332507200.17
单位质量响应值RSD%判断
25316.3325248.740.19数据可信
供试品溶液-2024092721批-贝派度酸-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min156440-5644022.26128.7927.8122.2628.7927.80
262332-6233224.58524.59
3112705-11270544.45344.45
469435-6943527.38727.39
573058-7305828.81628.82
663942-6394225.22025.22
10min1155030-15503061.14767.418.8361.3967.738.91
2161507-16150763.70263.98
3193739-19373976.41576.91
4175044-17504469.04169.35
5181432-18143271.56171.88
6158728-15872862.60662.89
15min1208000-20800082.04083.582.5082.9784.652.64
2208552-20855282.25883.24
3220541-22054186.98688.33
4213979-21397984.39885.47
5213971-21397184.39585.51
6206403-20640381.41082.39
20min1225116-22511688.79189.800.8790.6391.790.96
2226803-22680389.45691.35
3227936-22793689.90392.21
4228118-22811889.97591.98
5231062-23106291.13693.19
6226965-22696589.52091.40
30min1238335-23833594.00594.311.2696.8397.301.28
2236056-23605693.10695.99
3240076-24007694.69298.00
4244521-24452196.44599.45
5236934-23693493.45296.52
6238676-23867694.13997.01
45min1246927-24692797.39495.001.58101.2699.041.40
2239126-23912694.31798.24
3235948-23594893.06397.42
4243375-24337595.993100.07
5239685-23968594.53798.64
6240045-24004594.67998.60
60min1241218-24121895.14295.370.66100.09100.470.62
2240075-24007594.69199.66
3240134-24013494.714100.11
4243719-24371996.128101.28
5242330-24233095.581100.73
6243340-24334095.979100.95
极限1237665-23766593.74193.952.2299.75100.112.08
2230097-23009790.75696.78
3234561-23456192.51698.96
4243871-24387196.188102.40
5239807-23980794.585100.80
6243165-24316595.910101.95
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