盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.415198495198325194395194865196565196520.04
212.375201875203365202620.03
单位质量响应值RSD%判断
41873.6542058.370.32数据可信
供试品溶液-6030501批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327640-32764062.73461.728.0062.7361.728.01
2317853-31785360.86060.86
3278080-27808053.24553.24
4357933-35793368.53468.53
5323190-32319061.88261.88
6329385-32938563.06863.07
10min1495955-49595594.96295.862.1495.6696.542.17
2504498-50449896.59797.27
3484208-48420892.71393.30
4507721-50772197.21597.98
5514759-51475998.56299.25
6496653-49665395.09595.80
15min1525648-525648100.64798.541.98102.40100.291.97
2505539-50553996.79798.55
3502494-50249496.21497.84
4510548-51054897.75699.60
5526492-526492100.809102.59
6517143-51714399.019100.78
20min1535281-535281102.49298.872.99105.36101.722.96
2506553-50655396.99199.82
3494487-49448794.68197.37
4511025-51102597.847100.78
5530846-530846101.642104.55
6520044-52004499.574102.43
30min1518896-51889699.35498.581.93103.36102.521.93
2510727-51072797.790101.69
3501833-50183396.08799.83
4509669-50966997.588101.60
5530792-530792101.632105.66
6517273-51727399.044103.01
极限1501207-50120795.96798.101.58101.08103.141.53
2516409-51640998.878103.87
3510908-51090897.825102.64
4508483-50848397.361102.46
5525357-525357100.591105.75
6511686-51168697.974103.04
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