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%
19.993011583011473017973011103012373012900.10
210.033008903007753008320.03
单位质量响应值RSD%判断
30159.1629993.220.40数据可信
供试品溶液-1996053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%
5min1959-9590.6361.1342.300.641.1442.13
21169-11690.7750.78
32510-25101.6641.66
41588-15881.0531.05
51344-13440.8910.89
62696-26961.7881.79
10min12497-24971.6561.5114.491.661.5214.42
22132-21321.4141.42
32366-23661.5691.59
41761-17611.1681.18
52210-22101.4651.48
62722-27221.8051.82
15min13150-31502.0892.3110.082.112.3410.17
23602-36022.3892.41
33431-34312.2752.31
43187-31872.1132.14
53455-34552.2912.32
64117-41172.7302.77
20min13803-38032.5222.617.962.572.677.99
23772-37722.5012.55
34547-45473.0153.08
43681-36812.4412.49
53978-39782.6382.69
63856-38562.5572.63
30min14569-45693.0303.085.423.113.165.33
24931-49313.2703.35
34423-44232.9333.03
44595-45953.0473.12
54360-43602.8912.97
64952-49523.2843.38
45min14897-48973.2473.322.023.363.442.03
24966-49663.2933.41
34964-49643.2923.42
45126-51263.3993.51
54956-49563.2863.40
65142-51423.4103.54
60min15258-52583.4873.8522.613.634.0021.68
25479-54793.6333.78
35293-52933.5103.67
45213-52133.4573.60
58468-84685.6155.76
65100-51003.3823.55
极限15309-53093.5213.624.273.713.824.25
25485-54853.6373.83
35159-51593.4213.62
45356-53563.5523.74
55588-55883.7063.92
65819-58193.8594.07
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%
19.993012913012923012313013683012013012770.03
210.033011363007343009350.10
单位质量响应值RSD%判断
30157.8630003.490.37数据可信
供试品溶液-1996053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%
5min14394-43942.9132.1418.092.912.1418.07
23078-30782.0412.04
32976-29761.9731.97
42885-28851.9131.91
52862-28621.8981.90
63157-31572.0932.09
10min14218-42182.7972.438.472.832.458.57
23457-34572.2922.31
33759-37592.4922.51
43333-33332.2102.23
53567-35672.3652.39
63625-36252.4032.43
15min14967-49673.2933.372.473.363.422.38
25033-50333.3373.39
35217-52173.4593.51
45104-51043.3843.43
55222-52223.4623.51
64924-49243.2653.31
20min16009-60093.9844.016.104.084.105.98
25710-57103.7863.87
36728-67284.4614.55
46078-60784.0304.11
56071-60714.0254.11
65731-57313.8003.89
30min16854-68544.5444.788.254.694.927.96
27199-71994.7734.90
36664-66644.4184.56
48352-83525.5385.67
57016-70164.6524.78
67214-72144.7834.91
45min17819-78195.1845.064.585.385.254.43
27960-79605.2785.46
37883-78835.2275.41
47034-70344.6644.85
57691-76915.0995.28
67424-74244.9225.10
60min18618-86185.7145.702.325.975.942.23
28540-85405.6625.90
38399-83995.5695.81
48613-86135.7115.95
58454-84545.6055.84
68963-89635.9436.18
极限111752-117527.7925.8218.978.116.1318.12
28702-87025.7706.07
38647-86475.7336.04
48087-80875.3625.67
58863-88635.8766.18
66651-66514.4104.71
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