What ICH Q3B(R2): Impurities in New Drug Products requires
ICH Q3B(R2) sets thresholds for degradation products in new drug products based on maximum daily dose. The guideline addresses impurities arising during manufacture, storage, or stability testing of the drug product but excludes impurities already present in the drug substance (covered by Q3A). Reporting, identification, and qualification thresholds are dose-dependent. Compliance is foundational to ICH region marketing applications and to stability protocol design.
Pillar: Pharmaceuticals & Life Sciences · Authority: International Council for Harmonisation (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf
SHA-256 integrity: 9e7ed98a5d0dcca882ff5efb1e2366a61645f148ca1da5830bac2870a79a3db5
Primary Citations — 5 traced to source
- ICH Harmonised Tripartite Guideline Q3B(R2) Impurities in New Drug Products, June 2006
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products providing degradation context
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