The Certification of the Reference Material IRMM-435 for the Determination of Alkali leaching from Pharmaceutical Glass Containers

Abstract

The certification of the reference material IRMM-435 for the determination of the alkali release from the interior surface of glass containers for parenteral or injectable pharmaceutical solutions according to an adapted method based on the European Pharmacopoeia method and the International Standard ISO 4802 is described in detail.JRC.D.4-Isotope measurement