Fluticasonepropionate（丙酸氟替卡松）USP39.pdf

00:1080/USP39S2/web/file/usp39nf34s2_m34220.html Fluticasone Propionate (floo tik a sone proe pee oh nate). C25H31F3O5S 500.57 Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, (6α,11β,16α,17α)-S-(fluoromethyl) ester; S-Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene- 17β-carbothioate [80474-14-2]. DEFINITION Fluticasone Propionate contains NLT 98.0% and NMT 101.0% of C25H31F3O5S, calculated on the anhydrous, solvent-free basis. IDENTIFICATION • A. Infrared Absorption 〈 197M〉 • B. The retention time of the major peak of the Sample solution corresponds to that of the 00:1080/USP39S2/web/file/usp39nf34s2_m34220.html (1 of 6)2016-7-6 9:07:01 00:1080/USP39S2/web/file/usp39nf34s2_m34220.html Standard solution, as obtained in the Assay. ASSAY • Procedure Buffer: 1.15 g/L of monobasic ammonium phosphate, adjusted with phosphoric acid to a pH of 3.5 ± 0.05 Mobile phase: Methanol, acetonitrile, and Buffer (50:15:35) System suitability solution: 0.05 mg/mL of USP Fluticasone Propionate Resolution Mixture RS in Mobile phase Standard solution: 0.04 mg/mL of USP Fluticasone Propionate RS in Mobile phase Sample solution: 0.04 mg/mL of Fluticasone Propionate in Mobile phase Chromatographic system (See Chromatography 〈621〉, System Suitability.) Mode: LC Detector: UV 239 nm Column: 4.6-mm × 25-cm; 5-µm packing L1 Column temperature: 40° Flow rate: 1.5 mL/min Injection size: 20 µL System suitability Samples: System suitability solution and Standard solution [Note—The relative retention times for fluticasone propionate and fluticasone propionate related compound D are about 1.0 and 1.10, respectively.] Suitability requireme