Reference standard

A characterized material used as the yardstick in a test, especially in potency and content assays: the sample is measured against it in the same run and the result is expressed relative to it. The Japanese Pharmacopoeia has official reference standards for its monographs, while biologics manufacturers establish in-house primary and working reference standards and qualify each new lot against the previous one. Replacing a reference standard without a bridging study can shift every reported potency value. Japanese documents use this word and a near-synonym for reference material (標準物質) loosely, so check whether a compendial or an in-house standard is meant.