Impurezze: tutte le linee guida

                                                      Aggiornato il 22/04/2014
FDA
ANDAs: Impurities in Drug substances


ICH
Q3A (R2): Impurities in New Drug Substances
Q3B (R2): Impurities in New Drug Products
Q3C (R4): Impurities: Guideline for Residual Solvents
Q3D: Guideline for elemental impurities (draft)

HEALTH CANADA
Draft guidance for industry - Impurities in existing drug substances and products

AUSTRALIAN GOVERNMENT
Related impurities in drug substances and drug products

ALTRI DOCUMENTI
Qualification of impurities in drug substances and drug products (Karl A. Traul)