日本橙皮书数据库(Japanese Orange Book)
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药效分类活性成分剂型制剂特性规格
118Chlorpheniramine MaleateSalicylamideAcetaminophenAnhydrous CaffeinePowderImmediate-release0.5mg/g・45mg/g・25mg/g・5mg/g 3mg/g・270mg/g・150mg/g・30mg/g
参比标识标准制剂成分名剂型特性规格结果通知表面活性剂溶出液转速溶出规格
基准液其他
【详细】NEO-AMUNOLL Comb. Powderマレイン酸クロルフェニラミン(クロルフェニラミンマレイン酸塩)
Chlorpheniramine Maleate
PowderImmediate-release3mg/g33water  1.2  4  6.85015minutes:Not less than 75%(HPLC method)
【详细】NEO-AMUNOLL Comb. Powderサリチルアミド
Salicylamide
PowderImmediate-release270mg/g33water  1.2  4  6.85015minutes:Not less than 80%(HPLC method)
【详细】NEO-AMUNOLL Comb. Powderアセトアミノフェン
Acetaminophen
PowderImmediate-release150mg/g33water  1.2  4  6.85015minutes:Not less than 80%(HPLC method)
【详细】NEO-AMUNOLL Comb. Powder無水カフェイン
Anhydrous Caffeine
PowderImmediate-release30mg/g33water  1.2  4  6.85015minutes:Not less than 85%(HPLC method)
【详细】Pelex Comb. Gran.マレイン酸クロルフェニラミン(クロルフェニラミンマレイン酸塩)
Chlorpheniramine Maleate
GranulesImmediate-release3mg/g33water  1.2  4  6.85015minutes:Not less than 80%(HPLC method)
【详细】Pelex Comb. Gran.サリチルアミド
Salicylamide
GranulesImmediate-release270mg/g33water  1.2  4  6.85045minutes:Not less than 80%(HPLC method)
【详细】Pelex Comb. Gran.アセトアミノフェン
Acetaminophen
GranulesImmediate-release150mg/g33water  1.2  4  6.85045minutes:Not less than 80%(HPLC method)
【详细】Pelex Comb. Gran.無水カフェイン
Anhydrous Caffeine
GranulesImmediate-release30mg/g33water  1.2  4  6.85045minutes:Not less than 85%(HPLC method)
【详细】Pediatric Pelex Comb. Gran.マレイン酸クロルフェニラミン(クロルフェニラミンマレイン酸塩)
Chlorpheniramine Maleate
GranulesImmediate-release0.5mg/g33water  1.2  4  6.85015minutes:Not less than 85%(HPLC method)
【详细】Pediatric Pelex Comb. Gran.サリチルアミド
Salicylamide
GranulesImmediate-release45mg/g33water  1.2  4  6.85015minutes:Not less than 80%(HPLC method)
【详细】Pediatric Pelex Comb. Gran.アセトアミノフェン
Acetaminophen
GranulesImmediate-release25mg/g33water  1.2  4  6.85015minutes:Not less than 80%(HPLC method)
【详细】Pediatric Pelex Comb. Gran.無水カフェイン
Anhydrous Caffeine
GranulesImmediate-release5mg/g33water  1.2  4  6.85015minutes:Not less than 85%(HPLC method)
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