フェキソフェナジン塩酸塩 ( 日本薬局方記載条件 ) Fexofenadine Hydrochloride (The Japanese Pharmacopoeia)

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1 フェキソフェナジン塩酸塩 ( 日本薬局方記載条件 ) Fexofenadine ydrochloride (The Japanese Pharmacopoeia) F8A A) Standard solution* (. mg/ml ) System 8.. FC 5 B) Sample solution* ( mg/ml ) Cl FD 5 Column : YMC-Triart Phenyl (5 µm, nm) 5 X.6 mmi.d. Eluent : acetonitrile/buffer* /triethylae (5/65/) * Dissolve 7.5 g of a P and.96 g of acl in ml water, adjust p. with P Flow rate :. ml/ (adjust the flow rate so that the retention time of fexofenadine is about 9 ) Temperature : 5 Detection : UV at nm Injection : µl (The Japanese Pharmacopoeia 6th; Related substances) * All standard and sample solutions were prepared from supplied as a reagent for laboratory use.

2 Fexofenadine ydrochloride (The Japanese Pharmacopoeia) FB Standard solution* (.6 mg/ml ) Cl Column : YMC-Triart Phenyl (5 µm, nm) 5 X.6 mmi.d. Eluent : acetonitrile/buffer* /triethylae (5/65/) * Dissolve 7.5 g of a P and.96 g of acl in ml water, adjust p. with P Flow rate :. ml/ (adjust the flow rate so that the retention time of fexofenadine is about 9 ) Temperature : 5 Detection : UV at nm Injection : µl (The Japanese Pharmacopoeia 6th; Assay) * Standard solution was prepared from supplied as a reagent for laboratory use.

3 Fexofenadine ydrochloride (The United States Pharmacopeia) F8B A) Assay preparation* (Assay), Reference solution* (Related compounds) (.6 mg/ml ) 8 (Assay).. FE B) Test solution* (Related compounds) ( mg/ml ) Cl FF 5 Column : YMC-Triart Phenyl (5 µm, nm) 5 X.6 mmi.d. Eluent : acetonitrile/buffer* /triethylae (5/65/) * Dissolve 7.5 g of a P and.96 g of acl in ml water, adjust p. with P. Flow rate :.5 ml/ Temperature : 5 Detection : UV at nm Injection : µl (The United States Pharmacopeia 6th; Assay, Related compounds) * All standard and sample solutions were prepared from supplied as a reagent for laboratory use.

4 Fexofenadine ydrochloride Tablets (The Japanese Pharmacopoeia) F8C A) Standard solution* (.8 mg/ml ) F5E B) Sample solution* (.8 mg/ml ) 8 6 Cl F5B Column : YMC-Triart Phenyl (5 µm, nm) 5 X.6 mmi.d. Eluent : acetonitrile/buffer* (9/6) * Add 5 ml of acetonitrile/triethylae (/) to ml of acetic acid/water (7/998), adjust p 5.5 with P Flow rate :. ml/ (adjust the flow rate so that the retention time of fexofenadine is about 6 ) Temperature : 5 Detection : UV at nm Injection : µl (The Japanese Pharmacopoeia 6th Supplement ; Assay) * Standard solution was prepared from supplied as a reagent for laboratory use. * Sample solution was prepared from tablets.

5 Fexofenadine ydrochloride Tablets (The United States Pharmacopeia) F8D A) Standard solution* (.5 mg/ml ) F5C B) Sample solution* (.8 mg/ml ) 8 6 Cl F5D Column : YMC-Triart Phenyl (5 µm, nm) 5 X.6 mmi.d. Eluent : acetonitrile/buffer* (9/6) * Add 5 ml of acetonitrile/triethylae (/) to ml of acetic acid/water (7/998), adjust p 5.5 with P Flow rate :.5 ml/ Temperature : 5 Detection : UV at nm Injection : µl (The United States Pharmacopeia 6th; Assay) * Standard solution was prepared from supplied as a reagent for laboratory use. * Sample solution was prepared from tablets.