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USP Monograph

Meaning

A USP Monograph is a comprehensive, legally recognized document published in the United States Pharmacopeia (USP) that establishes the official standards for a specific drug substance, drug product, or dietary supplement ingredient. This authoritative document details the required specifications for identity, strength, quality, purity, and performance, including the precise testing procedures necessary to ensure compliance. Adherence to the monograph is critical for guaranteeing the reliability and safety of pharmaceutical and wellness products.