• Major New Instrumentation Investment for Extractables and Leachables Analysis


Major New Instrumentation Investment for Extractables and Leachables Analysis

Sep 23 2012

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.

Digital Edition

ILM 49.5 July

July 2024

Chromatography Articles - Understanding PFAS: Analysis and Implications Mass Spectrometry & Spectroscopy Articles - MS detection of Alzheimer’s blood-based biomarkers LIMS - Essent...

View all digital editions


ADLM 2024

Jul 28 2024 San Diego, CA USA

InaLab 2024

Jul 30 2024 Jakarta, Indonesia


Jul 31 2024 Chengdu, China

ACS National Meeting - Fall 2024

Aug 18 2024 Denver, CO, USA


Aug 25 2024 Copenhagen, Denmark

View all events