Japanese–English glossary
Limit of quantitation (LOQ)
Also called quantitation limit
LOQ（定量限界）LOQ (teiryō genkai)
Also written 定量限界
The lowest amount of analyte that can be quantified with suitable precision and accuracy. It is required for quantitative impurity tests and must lie below the specification limit, preferably well below it. Results under the LOQ are reported as less than the LOQ, and the procedure should define how such results are handled in trending and statistics. ICH Q2(R2) treats the quantitation limit as the lower end of the range for impurity methods. Japanese documents use LOQ and the Japanese term interchangeably.