monograph

A monograph is the dedicated page (or set of pages) in a pharmacopoeia for one specific article — say, a particular drug substance or a tablet of it. It is like the official spec sheet for that item: read it and you know what the article is and how to confirm it is genuine and good enough.

A typical monograph names the article and gives its definition (including acceptable content range, such as 95.0–105.0 percent of label claim), then lists tests: identification to prove it is the right substance, an assay to measure how much active is present, and purity tests for impurities, water content, and residual solvents. For a dosage form it adds product-specific tests such as dissolution, disintegration, or uniformity of dosage units. Methods are often spelled out by reference to general chapters rather than repeated in full.

Monographs set public minimum standards, so two manufacturers can use different processes yet both demonstrate compliance against the same yardstick. They are not a complete description of a brand-name product's full registered specification, which may include extra tests not in the compendium.