Page 2 - Shimadzu’s Solutions for Impurities Analysis

Support for the New Impurities in

Pharmaceuticals Regulations

The existing three guidelines for impurities in
pharmaceuticals were agreed on and notified by the
International Conference on Harmonization (ICH). The
analysis of impurities is already prescribed across a wide
range, from organic impurities to inorganic impurities.

ɾ Impurities in New Drug Substances (ICH Q3A)
ɾ Impurities in New Drug Products (ICH Q3B)
ɾ Impurities: Guideline for Residual Solvents (ICH Q3C)

The U.S. Food and Drug Administration (FDA) recently
issued a draft guidance, "Guidance for Industry: Genotoxic
and Carcinogenic Impurities in Drug Substances and
Products: Recommended Approaches." This demands the
structural analysis and quality control of lower trace levels
of organic impurities than prescribed in the ICH guidelines.
In addition, the FDA "Guidance for Industry: Residual
Solvents in Drug Products Marketed in the United States"
demands new measures to tackle residual solvents.
This brochure explains the new regulations by the U.S. FDA
and our solutions to respond to those regulations.