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Epirubicin hydrochloride API is the hydrochloride salt of epirubicin, a semi-synthetic anthracycline antineoplastic antibiotic that serves as the 4'-epimer of doxorubicin and is derived from daunorubicin. Its chemical name is (8S-cis)-10-[(3-amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione hydrochloride, with the molecular formula C27H29NO11·HCl and a molecular weight of 579.98. The active moiety is a red-orange hygroscopic powder that exerts its antitumor effects through multiple mechanisms, including intercalation of its planar rings between DNA base pairs to inhibit nucleic acid and protein synthesis, stimulation of topoisomerase II-mediated DNA strand breaks, and generation of cytotoxic free radicals via redox cycling. The API is manufactured via a semi-synthetic process that begins with microbial fermentation of appropriate Streptomyces strains to produce daunorubicin or 4'-epi-daunorubicin precursors, followed by chemical modification to invert the stereochemistry at the 4' position of the daunosamine sugar moiety. Key steps include formation of bromo-ketal intermediates, hydrolysis, oxidation, and purification through ion-exchange resins in chloride form, followed by adsorption chromatography, concentration, and final crystallization of the hydrochloride salt under controlled pH and solvent conditions to achieve pharmacopeial purity and stability. Epirubicin hydrochloride is indicated as a component of adjuvant therapy in patients with primary breast cancer and axillary lymph node involvement following surgical resection, where it is administered intravenously in combination regimens to reduce recurrence risk. It is also used in the treatment of advanced or metastatic breast cancer and other malignancies including gastric carcinoma, ovarian carcinoma, lung carcinoma, soft-tissue sarcomas, malignant lymphomas, and certain leukemias, with dosing individualized according to body surface area and hepatic function to balance efficacy against risks of myelosuppression and cumulative cardiotoxicity.
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