日本橙皮书数据库(Japanese Orange Book)
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再评价结果通知号及日期19
2004/2/23
药效分类251
Agents affecting urinary organs
商品名URONAMIN Enteric-Coated Tab.
活性成分Hexamine Mandelate
活性成分(日文)マンデル酸ヘキサミン
剂型Tablets
规格250mg
特性Enteric-coated
转速Paddle Method,75rpm
溶出液基准液:1.2  6.8
其他:6  water  
溶出规格120minutes(pH1.2): Not more than 5%; 90minutes(pH6.8):Not less than 85%(HPLC method)
溶出曲线测定例
成分名称:マンデル酸ヘキサミン   英文名:Hexamine Mandelate   含量:250mg
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