ICH Q3A and Q3B
Two International Council for Harmonisation guidelines on impurities in new drug substances (Q3A) and new drug products (Q3B). They set reporting, identification and qualification thresholds that depend on the maximum daily dose. Impurities above the identification threshold must be structurally characterised, and those above the qualification threshold need safety justification. Reference standards are needed to quantify these impurities reliably.
Related terms
API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs…
ICH M7
The ICH guideline on assessment and control of DNA-reactive, potentially mutagenic impurities in pharmaceutic…
LOD and LOQ
The limit of detection (LOD) is the lowest amount of analyte that a method can reliably distinguish from back…
Reference Standard
A highly characterised material used as a benchmark to confirm identity, measure assay or quantify impurities…
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