ICH Q3A/B
ICH Q3A(R2) / Q3B(R2) — Impurities in New Drug Substances / Products · ich q3a · ich q3b · impurities guideline
ICH guidelines setting reporting, identification, and qualification thresholds for organic impurities in drug substances (Q3A) and drug products (Q3B).
ICH Q3A and Q3B define how organic impurities must be reported, identified, and qualified at three thresholds tied to maximum daily dose. They drive how analytical methods are developed, how specifications are justified, and how stability and forced-degradation data are interpreted.
V5 links each impurity specification to the LIMS method, stability protocol, and change-control history so a regulator can trace a single peak from the method to the approved limit.
- ICH Q3A(R2)
- ICH Q3B(R2)
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