Quality: impurities
The European Medicines Agency's scientific guidelines on impurities in drug products and drug substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Control of impurities of pharmacopoeial substances - Scientific guideline
- ICH Q3A (R2) Impurities in new drug substances - Scientific guideline
- ICH Q3B (R2) Impurities in new drug products - Scientific guideline
- ICH Q3C (R8) Residual solvents - Scientific guideline
- ICH Q3D Elemental impurities - Scientific guideline
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
- Setting specifications for related impurities in antibiotics - Scientific guideline