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%
1 15.943820638475383803844338439383890.29
2 15.973938139092392360.53
单位质量响应值RSD%判断
2408.342456.861.42数据可信
供试品溶液-2025030422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%
5min15617-561712.96414.2219.3612.9614.2219.36
27284-728416.81116.81
36947-694716.03316.03
47385-738517.04417.04
54637-463710.70210.70
65105-510511.78211.78
10min115122-1512234.90140.0116.3234.9240.0316.32
220628-2062847.60847.64
318964-1896443.76843.79
419987-1998746.12946.16
514380-1438033.18833.21
614925-1492534.44634.47
15min125055-2505557.82662.339.4457.9162.429.45
229774-2977468.71768.82
328460-2846065.68465.78
429550-2955068.20068.31
523946-2394655.26655.34
625252-2525258.28058.36
20min132655-3265575.36677.734.2075.5477.924.22
235352-3535281.59081.81
334437-3443779.47979.69
435012-3501280.80681.02
532340-3234074.63974.80
632269-3226974.47574.65
30min139818-3981891.89892.041.0592.2092.361.04
239874-3987492.02792.38
339460-3946091.07291.41
440172-4017292.71593.07
540515-4051593.50693.80
639442-3944291.03091.33
45min142322-4232297.67798.121.7598.1398.601.73
242674-4267498.48999.00
342812-4281298.80899.30
441333-4133395.39495.90
542351-4235197.74498.19
643601-43601100.629101.08
60min142016-4201696.97198.111.1397.5998.751.12
242330-4233097.69598.37
342823-4282398.83399.49
442507-4250798.10498.77
543286-4328699.902100.51
642090-4209097.14197.76
极限143225-4322599.76199.571.50100.54100.381.48
243593-43593100.610101.45
342253-4225397.51898.34
442819-4281998.82499.65
544095-44095101.769102.54
642876-4287698.95599.74
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