The aim of this study was to conduct a comparative analysis of regulatory requirements for the quality of fluoxetine substance and finished dosage forms in accordance with leading pharmacopoeias (EP, USP, BP, IP, State Pharmacopoeia of the Russian Federation) and national regulatory documents of the Republic of Uzbekistan. Using a systematic analysis method, 19 quality control parameters of the substance were compared, and a detailed comparison of specifications for four registered finished dosage forms was carried out. The results showed that all pharmacopoeias are consistent in their basic requirements; however, significant differences exist in critical parameters of finished dosage forms. Based on the findings, recommendations were proposed for harmonizing requirements within the Eurasian Economic Union (EAEU) and Central Asia, with reference to EP 11.0 as the most detailed pharmacopoeial monograph.
