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%
111.239762679722279762399718259733379739790.23
211.299713319710729712020.02
单位质量响应值RSD%判断
86730.1086023.210.58数据可信
供试品溶液-2024092721批-依折麦布-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%
5min149463-494635.1414.975.655.144.975.58
249250-492505.1195.12
344693-446934.6454.65
10min158255-582556.0555.1415.706.115.2015.49
243475-434754.5194.58
346733-467334.8574.91
15min175018-750187.7977.891.097.928.000.96
276622-766227.9648.07
376115-761157.9118.02
20min176746-767467.9778.006.458.198.216.28
272188-721887.5037.70
382099-820998.5338.73
30min180530-805308.3708.073.458.678.363.43
277049-770498.0088.29
375275-752757.8248.11
45min183021-830218.6298.555.139.028.935.00
277782-777828.0848.45
386120-861208.9519.33
60min194442-944429.8168.5213.2810.308.9912.71
274798-747987.7748.23
376549-765497.9568.43
极限199723-9972310.3659.1812.7510.969.7412.28
277219-772198.0268.57
387956-879569.1429.70
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%
19.922512942506652514182501982512012509550.21
29.932507022509622508320.08
单位质量响应值RSD%判断
25297.8825260.020.11数据可信
供试品溶液-2024092721批-贝派度酸-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%
5min189739-8973935.40033.9310.3335.4033.9310.33
292419-9241936.45736.46
375876-7587629.93129.93
10min197682-9768238.53329.0628.2738.9329.4427.95
260798-6079823.98424.39
362502-6250224.65624.99
15min1186418-18641873.53876.974.5874.3677.674.45
2204263-20426380.57781.25
3194697-19469776.80477.41
20min1185029-18502972.99064.2314.6474.6365.7914.33
2137663-13766354.30555.87
3165806-16580665.40766.87
30min1227780-22778089.85490.471.7892.3092.741.68
2233948-23394892.28794.46
3226272-22627289.25991.45
45min1224587-22458788.59582.9910.2492.0486.269.95
2185608-18560873.21876.41
3220955-22095587.16290.34
60min1228567-22856790.16592.432.3694.6096.632.10
2234796-23479692.62296.63
3239555-23955594.49998.65
极限1232620-23262091.76487.885.9597.2093.105.81
2207701-20770181.93486.97
3227978-22797889.93295.13
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