specification

A specification is the agreed checklist a material or product must pass: a defined list of tests, the methods used, and the acceptance limits for each. It is the pass-or-fail contract — if every result is within its limit, the batch conforms; if one fails, it does not.

A typical finished-product specification names tests such as description, identification, assay, related substances, dissolution, content uniformity, water content, and microbial quality, and pairs each with a reference to its analytical method and a numeric limit (for example, assay 95.0–105.0 percent of label claim). Specifications exist for starting materials, intermediates, the drug substance, and the finished product, and they apply both at release and through the shelf life — release and end-of-shelf-life limits sometimes differ to allow for expected change over time.

Specifications are justified by data: limits should be set from clinical, toxicological, manufacturing, and stability information, not chosen arbitrarily. A compendial monograph sets public minimum limits, but a manufacturer's registered specification is often tighter or includes extra tests beyond the pharmacopoeia.