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Allen Kesselring, Ph.D. of EAG Life Sciences Featured in Special Report on Extractables and Leachables
Date:12/13/2012

Maryland Heights, Missouri (PRWEB) December 13, 2012

Allen Kesselring, Ph.D. , Scientific Director of EAG Life Sciences, recently participated in an industry roundtable for a special report on extractables and leachables (E&L) testing, published in the November 2012 issue of Pharmaceutical Technology and featured online at Pharmtech.com. Extractables and leachables continue to challenge the pharmaceutical industry, stirring increasing concerns from manufacturers. E&L investigations focus on potential organic and inorganic impurities released or migrated from packaging components into pharmaceutical products.

In the special report, “Examining the Growing Challenge of Extractables and Leachables”, Dr. Kesselring noted that these studies are most commonly associated with injectables, ophthalmics, and orally inhaled nasal drug products. The routes of drug delivery, length and quantity of exposures make for important considerations in extractable and leachable studies. Dr. Kesselring explains: “The quick and efficient transport of ingredients to the bloodstream, which makes these drug-delivery routes highly effective, also makes them susceptible to impurities arising from the packaging."

In the report, the roundtable experts discussed the changes and advancements in analytical testing for extractables and leachables. Dr. Kesselring explained that while analytical improvements have led to faster, more efficient assessments of E&Ls they have also allowed for increased regulatory expectations. He mentioned recent regulatory initiatives that require more specificity and lower limits of evaluation, such as the forthcoming USP General Chapters 232 and 233 involving elemental impurities and the “published for comment” glass delamination document of 1660.

More published information on extractables and leachables from Dr. Kesselring include:

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