坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.947364773716732207330873458734700.29
215.977438574309743470.08
单位质量响应值RSD%判断
4609.164655.420.71数据可信
每杯投2片--供试品溶液-2025011621批-pH6.8(内含0.1%Tween80)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112540-1254015.19716.286.4815.2016.296.48
214389-1438917.43817.44
312186-1218614.76814.77
413755-1375516.67016.67
513776-1377616.69516.70
613980-1398016.94216.94
10min136038-3603843.67544.973.8143.7044.993.81
237559-3755945.51845.55
334760-3476042.12642.15
438053-3805346.11746.14
537763-3776345.76545.79
638444-3844446.59046.62
15min154586-5458666.15367.171.6966.2567.271.69
254918-5491866.55566.66
354355-5435565.87365.97
456003-5600367.87067.97
555987-5598767.85167.95
656683-5668368.69468.80
20min167103-6710381.32281.221.2581.5381.431.26
265594-6559479.49479.71
366759-6675980.90681.11
467454-6745481.74881.97
567072-6707281.28581.50
668120-6812082.55582.78
30min177645-7764594.09893.961.4094.4494.311.39
275623-7562391.64892.00
377247-7724793.61693.96
477613-7761394.06094.41
578313-7831394.90895.26
678743-7874395.42995.79
45min180740-8074097.84998.431.0998.3598.941.09
279931-7993196.86997.37
381326-8132698.55999.05
480929-8092998.07898.59
582206-8220699.626100.14
682175-8217599.588100.11
60min180721-8072197.82698.471.3198.4999.141.30
280120-8012097.09897.76
381298-8129898.52599.19
480347-8034797.37398.05
582646-82646100.159100.84
682371-8237199.826100.51
极限180485-8048597.54098.341.0398.3799.181.03
280823-8082397.95098.77
380691-8069197.79098.61
480468-8046897.52098.36
582309-8230999.751100.59
682106-8210699.505100.35
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.947376773553735277362373413735770.18
215.977387573990739320.11
单位质量响应值RSD%判断
4615.874629.430.21数据可信
每杯投2片--供试品溶液-2025011621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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11584-15841.9242.0214.801.922.0214.85
21370-13701.6641.66
31889-18892.2942.29
42033-20332.4692.47
51613-16131.9591.96
61514-15141.8391.84
15min13107-31073.7733.7310.673.783.7310.65
23129-31293.8003.80
33425-34254.1594.16
43084-30843.7453.75
53218-32183.9083.91
62451-24512.9772.98
20min14593-45935.5785.1513.555.595.1613.57
23989-39894.8444.85
34514-45145.4825.49
44997-49976.0686.08
53994-39944.8504.86
63370-33704.0934.10
30min14471-44715.4305.596.295.455.616.26
24926-49265.9826.00
34788-47885.8155.83
44791-47915.8185.84
54134-41345.0205.04
64516-45165.4845.50
45min14824-48245.8586.196.255.896.216.23
24971-49716.0376.06
35498-54986.6776.71
44755-47555.7745.80
55465-54656.6376.66
65051-50516.1346.16
60min15299-52996.4356.541.586.476.581.56
25458-54586.6286.67
35258-52586.3856.43
45417-54176.5786.62
55460-54606.6316.67
65399-53996.5576.59
极限15836-58367.0876.239.087.146.289.07
25261-52616.3896.44
35171-51716.2806.33
44671-46715.6725.72
55279-52796.4116.46
64553-45535.5295.57
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