Reference Standard
A highly characterised material used as a benchmark to confirm identity, measure assay or quantify impurities. Its value comes from documented purity, traceability and stability rather than simply from high purity. Primary standards are issued by pharmacopoeias or national metrology bodies, while secondary standards are qualified against them. Each standard should come with a certificate stating its assigned value and use.
Related terms
Certificate of Analysis (COA)
A document issued for a specific lot that lists each specification test, its acceptance limit and the result…
ISO 17034
The international standard that sets general requirements for the competence of reference material producers.…
Pharmacopoeia
An official book of quality standards for medicines and their ingredients, with legal status in the countries…
Secondary Standard
A working reference standard whose identity and potency have been established by comparison with an official…
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