贝派度酸片项目信息
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对照品来源自制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50
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%
19.972983912993302994282986752993972990440.17
210.052988322990592989460.06
单位质量响应值RSD%判断
29994.3829745.870.59数据可信
供试品溶液-24072201批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12193-21931.4641.2910.181.461.2910.08
21964-19641.3111.31
31932-19321.2901.29
41893-18931.2641.26
52050-20501.3691.37
61600-16001.0681.07
10min13627-36272.4222.424.082.442.444.04
23728-37282.4892.50
33737-37372.4952.51
43731-37312.4912.51
53358-33582.2422.26
63565-35652.3802.39
15min14330-43302.8912.911.872.932.951.84
24234-42342.8272.87
34356-43562.9092.95
44460-44602.9783.02
54331-43312.8922.93
64434-44342.9613.00
20min14999-49993.3383.303.993.413.373.87
24717-47173.1503.22
34735-47353.1623.24
45207-52073.4773.55
54886-48863.2623.33
65096-50963.4033.47
30min15338-53383.5643.562.513.683.672.40
25576-55763.7233.83
35288-52883.5313.64
45274-52743.5213.63
55306-53063.5433.65
65177-51773.4573.57
45min15634-56343.7623.693.583.913.843.41
25655-56553.7763.93
35363-53633.5813.73
45309-53093.5453.70
55425-54253.6223.77
65816-58163.8834.03
60min15559-55593.7123.721.393.913.911.33
25583-55833.7283.92
35425-54253.6223.81
45567-55673.7173.91
55614-56143.7483.94
65649-56493.7723.96
极限15579-55793.7253.791.783.964.021.70
25714-57143.8154.05
35581-55813.7263.96
45645-56453.7694.00
55701-57013.8074.04
65847-58473.9044.14
贝派度酸片项目信息
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对照品来源自制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50
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%
19.972978682977422969972973612973252974590.12
210.052969602970242969920.02
单位质量响应值RSD%判断
29835.4129551.440.68数据可信
供试品溶液-24072201批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13591-35912.4122.168.972.412.168.99
22921-29211.9621.96
33059-30592.0552.05
42972-29721.9962.00
53227-32272.1682.17
63539-35392.3772.38
10min16191-61914.1584.208.224.194.228.21
26200-62004.1644.19
35861-58613.9373.96
45696-56963.8263.85
57164-71644.8124.84
66385-63854.2894.32
15min18141-81415.4685.552.495.545.622.46
28145-81455.4715.54
38297-82975.5735.64
48377-83775.6275.69
58613-86135.7855.86
68047-80475.4055.48
20min17541-75415.0655.035.495.205.175.37
27309-73094.9095.04
37772-77725.2205.35
47382-73824.9585.09
58080-80805.4275.57
66881-68814.6224.76
30min18955-89556.0156.194.206.206.384.14
28940-89406.0056.19
39315-93156.2576.44
48783-87835.8996.08
59572-95726.4296.63
69744-97446.5456.73
45min19250-92506.2136.836.956.477.096.77
29710-97106.5226.77
39923-99236.6656.92
410299-102996.9187.17
510608-106087.1257.40
611253-112537.5587.82
60min110239-102396.8776.644.037.206.973.89
29826-98266.6006.92
39733-97336.5376.87
49425-94256.3316.66
510480-104807.0397.39
69612-96126.4566.80
极限110050-100506.7506.783.747.157.193.64
29958-99586.6897.08
39778-97786.5686.97
410380-103806.9727.37
510697-106977.1857.62
69715-97156.5256.94
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