Farmacopea De Los Estados Unidos Mexicanos
The Farmacopea de los Estados Unidos Mexicanos (FEUM) is Mexico's official document that establishes the quality, purity, and identity standards for medicines and health supplies.
Regular Updates: The publication is periodically revised; the 13th Edition was launched in 2022, followed by Supplement 13.1 in 2023. Key Regulatory Functions Perspectives for licensing vaccines in Mexico - PMC farmacopea de los estados unidos mexicanos
4. Structure and Content
The FEUM is divided into several sections: The Farmacopea de los Estados Unidos Mexicanos (FEUM)
- Chemical name, CAS number, molecular formula, molecular weight
- Physical description
- Identification tests (IR, UV, TLC, HPLC, etc.)
- Purity tests (heavy metals, residual solvents, related substances)
- Assay methods (typically HPLC, titration)
- Storage conditions
Important nuance: If a drug is not covered by a FEUM monograph, manufacturers may refer to USP, Ph. Eur., or JP — but must justify use. However, in case of conflict, FEUM prevails in Mexico. manufacturers may refer to USP
Estructura y Contenido: ¿Qué regula exactamente la FEUM?
La FEUM no es un libro monolítico; es un sistema vivo organizado en suplementos y fascículos. Su contenido se divide en varias categorías clave:
was formally instituted to ensure the book never became a relic of the past. It became a living document, constantly updated to include modern biotechnological products and rigorous chemical analysis methods like High-Performance Liquid Chromatography (HPLC). The Modern Silent Watchman Today, the FEUM exists in its 13th edition