COA: certificate of analysis, the test report for one lot.

Lot or batch: one production run. Each lot gets its own report.

HPLC: high performance liquid chromatography, a test that separates a sample into its parts.

Mass spectrometry: a test that measures the mass of molecules to help confirm identity.

Specificity: a test's ability to pick out the target compound when other substances are present.

Detection limit: the smallest amount a test can detect, though not always measure exactly.

Quantitation limit: the smallest amount a test can measure with suitable precision and accuracy.

Counter ion: a salt partner, such as trifluoroacetate, that stays with the compound after it is made.

EU: endotoxin unit, the scale used to report endotoxin results.

Sources: Definitions of specificity, detection limit and quantitation limit follow ICH Q2(R2), 2023; counter ions, D'Hondt M et al., 2014, PMID 25044089.

	Criado por Peptara Labs 15 dias atrás

How to read a certificate of analysis, step by step: the header, identity, purity, amount and safety lines, plus a glossary and a self-check list.

How to Read a Certificate of Analysis: A Study Guide