Major New Instrumentation Investment for Extractables and Leachables Analysis

ICH Topic Q6A, MHRA and EMEA all require the evaluation and quantitation of extractable and leachable materials from containers and closure systems. The data generated needs to effectively demonstrate that extractables from any part of the delivery systems in contact with drug product are at levels considered safe to use.

Mass Spectrometry experts Hall Analytical and Chromatography experts Crawford Scientific offer a unique partnership in extractable and leachable analysis, with a range of validated methods for the analysis of a wide range of components, sales, tubing, closures and packaging.

The partnership has recently undergone a large instrument investment program to ensure that their analytical capability in terms of extraction, identification and quantitation stays at the cutting edge.

“The recent acquisition of Time-of-Flight, MS/MS and GC/MS equipment will enable the elucidation of materials to increasingly lower levels. The range of analytes which can be detected within our lab has now been significantly extended.”Christophe Auberger, Technical Business Development Manager at Crawford Scientific.

As a result of many years experience, we have a defined strategy for Controlled Extraction Studies which satisfy the PQRI requirements, whilst presenting our clients with a flexible and cost effective way to undertake this important safety evaluation analysis. We excel in data reporting and interpretation for regulatory submission.