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RESEARCH ARTICLE
Contents Vol 58(12)

Evaluation of Aqueous Extracts from Elast-Eon Polymers for Methylene Dianiline (MDA) by High-Performance Liquid Chromatography (HPLC)

Ramasri Mudumba A , Ajay D. Padsalgikar A C and Stuart W. Littler B
+ Author Affiliations
- Author Affiliations

A AorTech Biomaterials, 677 Springvale Road, Mulgrave VIC 3170, Australia.

B CSIRO Molecular and Health Technologies, Clayton South VIC 3169, Australia.

C Corresponding author. Email: ajayp@aortechbio.com

Australian Journal of Chemistry 58(12) 845-850 https://doi.org/10.1071/CH05240
Submitted: 1 September 2005  Accepted: 6 December 2005   Published: 20 December 2005

Abstract

Elast-Eon polymers are a class of materials suitable for use in long-term implantable medical devices. They are the copolymers of methylene diphenyl diisocyanate (MDI) based polyurethanes and hydroxyl-terminated polydimethyl siloxane, and as a result combine the biostability and biocompatibility of silicones with the mechanical properties of polyurethanes. In order to ensure product safety and meet regulatory requirements, it is important to confirm the absence or presence of toxic 4,4′-methylene dianiline (MDA) in aqueous extracts of Elast-Eon. The present work focusses on the development of an analytical technique to detect any leachable MDA from Elast-Eon polymers. No traces of MDA could be detected in the aqueous extracts from Elast-Eon, or from sterilized and aged (accelerated oxidized) samples of Elast-Eon.


Acknowledgments

The authors thank CSIRO Molecular and Health Technologies for providing HPLC facilities for this investigation.


References


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