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.
Maryland Heights, MO (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:
- “Quantitative Determination of Extractables and Leachables within a Product Container Closure System by GC/MS”, a poster presentation by Dr. Kesselring, 2012 American Association of Pharmaceutical Scientists (AAPS) and case study of an E&L investigation.
- “Extractables and Leachables for Pharmaceuticals and Medical Devices” This white paper defines extractables and leachables and outlines an E&L study plan that is scientifically relevant and compliant within GXP regulatory systems.
About Allen Kesselring, Ph.D.
Allen Kesselring, Ph.D. serves as the Scientific Director of EAG Life Sciences. He maintains the scientific excellence, quality and timeliness of the contract research organization’s projects. In this role he serves as technical client liaison regarding GXP compliance. He may be reached for further questions at info(dot)lifesciences(at)eaglabs(dot)com or 800-659-6059.
About EAG Life Sciences
EAG Life Sciences is a contract laboratory with over 50 years of experience supporting pharmaceutical and medical device companies for their specialized research and development needs. Key services include analytical chemistry, method development and method validation, characterization, extractables and leachables studies, quality control testing and stability services. Clients receive high level of 1:1 technical interaction and responsiveness that is applied to both complex and routine studies. EAG Life Sciences is a division of Evans Analytical Group, global company providing technical services rooted in science. http://www.eag.com.