Navigation Links
Allen Kesselring, Ph.D. of EAG Life Sciences Featured in Special Report on Extractables and Leachables

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 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:

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 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.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Marketing Xocolate International Corporation; Xocai, Announces Their 12-Week Weight Loss Challenge To Make Healthy Changes
2. Xocai Maryland
3. Xocai Massachusetts
4. Studies challenge standards to improve treatment outcomes for patients with clotting disorders
5. Research from ASCOS Quality Care Symposium shows advances and challenges in improving the quality of cancer care
6. Complications challenge rheumatoid arthritis patients after joint replacement surgery
7. Teen Smoking Has Fallen Across Most of U.S.: Report
8. Obese but happy gene challenges the common perception of link between depression and obesity
9. HIV and AIDS prevention--Progress and the challenges ahead
10. People in crowdsourcing challenge find defibrillators in Philadelphia
11. Weill Cornell receives $1.5 million in Grand Challenges Explorations grants
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... ChiliPad , ... to maximize recovery through quality sleep. Tim DiFrancesco, training coach for the LA ... night’s sleep. ChiliPad precisely regulates the surface temperature of each side of the ...
(Date:11/30/2015)... ... 2015 , ... Using a combination of two blood sugar tests rather than ... to a new study by researchers at the School of Public Health at Georgia ... Combinations of Blood Glucose Tests ,” published in Frontiers in Public Health, the researchers ...
(Date:11/30/2015)... ... November 30, 2015 , ... Newly reviewed and approved “NJ Top Dentist”, ... Tufts School of Dental Medicine in 1935. His father graduated from NYU School ... in dentistry as well as their commitment and passion to the Practice of Dentistry. ...
(Date:11/30/2015)... New York, NY (PRWEB) , ... November 30, 2015 , ... ... New York Times,” will be released on December 1, 2015, to coincide with World ... book about the groundbreaking journalist who covered the AIDS epidemic as he was dying ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for Clinical ... of World AIDS Day 2015. On Nov. 30, ASCP shared its “Give a minute. ... World AIDS Day and the importance of getting tested for HIV. , ASCP has ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... , Nov. 30, 2015   Royal Philips ... the launch of Radiology Solutions, a fully integrated, ... Solutions comprises customized, data-driven practice management approaches that ... help radiology practices improve care delivery and reduce ... Radiological Society of North America Annual Meeting (RSNA) ...
(Date:11/30/2015)... , Nov. 30, 2015  IBA Molecular North ... and distribution of radiopharmaceuticals, announced that as of January ... Inc. (Zevacor Pharma). The decision to rebrand the company ... firm as well as its close relationship with Zevacor ... Illinois Health and Science (IHS). Peter ...
(Date:11/30/2015)... BOCA RATON, Fla. , Nov. 30, 2015 ... Public Research (the Institute) announced today that it ... a medical device start-up company with technology developed at ... based on publicly-funded research, and bridges early funding gaps ... -based universities and research institutions. ...
Breaking Medicine Technology: