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Abstract

This report 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 European Pharmacopoeia method and the International Standard ISO 4802. The material has been certified for its alkali leaching and release determined by titration and for its sodium leaching and release determined by flame spectrometry.

Additional information

Authors: WÄTJEN U, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);GUADAGNINO E, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE);PETERS A, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel (BE)
Bibliographic Reference: EUR 22537 EN (2006), various paging. Free of charge
Availability: http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=LANA22537 (Catalogue Number: LA-NA-22537-EN-C)
ISBN: ISBN: 92-79-03798-6
Record Number: 200718856 / Last updated on: 2007-03-01
Category: PUBLICATION
Original language: en
Available languages: en
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