The Certification Of The Reference Material Irmm-435 For The Determination Of Alkali Leaching From Pharmaceutical Glass Containers

This paper describes 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 EU Pharmacopoeia & ISO 4802. Preliminary studies showed that an acceptable reproducibility between laboratories could only be achieved when taking some additional measures which are neither required by EP or ISO method, such as: Etching the vials prior to autoclave procedure; Capping vials with closures of the design described; Measuring the temperature in the actual vials (not in the autoclave atmosphere around them) using a calibrated thermocouple; Recording the rate of temperature rise vs time; Adding an ionisation buffer to the extract solutions for flame spectrometric measurements; Simulating the buffer additions to the leachate in the calibration solutions. Consequently, a modified version of the ISO method was defined & used for the subsequent certification work.