ENCO Provides Testing Support to Meet New FDA Hand Sanitizer Requirements
New FDA guidance has recently been released related to the safety of hand sanitizers. The new guidance identifies the requirement of testing additional impurities in these products.
JACKSONVILLE, Fla., Sept. 1, 2020 /PRNewswire-PRWeb/ -- As a part of the FDA's temporary guidance related to the safety of hand sanitizers, the United States Pharmacopeia (USP) is providing additional direction on its quality standard related to these products.
Effective today, analytical test methods designed to monitor for the presence of potentially harmful impurities will be provided by USP and are to be applied to these critical products which are labelled with either ethanol or isopropyl alcohol as ingredients.
ENCO Pharmaceutical Development, Inc. (EPDI) has been providing support for testing these impurities for nearly 20 years and is prepared to assist the industry as these guidelines are rolled-out.
"We know the industry is in need of a "go-to" organization that can move quickly to assist in getting these products screened and released as rapidly as possible," said Rick Camp, President of EPDI. Keith Hurley, the Vice-President of Business Development and Marketing added, "We are focused on getting the job done for our clients. We have a highly trained and well-equipped staff skilled in analytical chemistry and capable of providing the necessary technical support to allow our clients to screen their products for impurities."
EPDI continues to expand its facilities and capabilities to accommodate the growing needs of the pharmaceutical, animal health care and medical device industries.
FDA Guidance:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
USP Reference:
https://www.usp.org/covid-19/hand-sanitizer-information
About the Company:
ENCO Pharmaceutical Development Inc. provides a broad spectrum of pharmaceutical development and analytical services from its facilities in Jacksonville, FL and Cary, NC. The company works with a variety of organizations in the pharmaceutical, animal health and medical device industries, including global, mid-size and small firms, as well as virtual organizations. EPDI provides expertise in formulation development and provides analytical support for method development and validation, stability studies, raw materials testing, extractable/leachable studies, medical device testing and more. For additional information, please visit http://www.encopharma.com or visit us on our LinkedIn page at https://www.linkedin.com/company/enco-pharmaceutical-development-inc-/?viewAsMember=true
CONTACT:
Keith Hurley
ENCO Pharmaceutical Development, Inc.
(o) 336-541-3270
(f) 904.296.6210
[email protected]
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SOURCE EPDI
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