Extractables and Leachables Analysis: Experts Present Proven Approaches for Solving Complex Analytical Challenges
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Extractables and Leachables Analysis: Experts Present Proven Approaches for Solving Complex Analytical Challenges

November 9, 2017

First Session: November 9, 2017: 9:00am EST, 6:00am PST, 14:00 GMT, 15:00 CET

Repeat Session: November 9, 2017: 12:00pm EST, 9:00am PST, 17:00 GMT, 18:00 CET

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Overview

 

The webinar will review the basics and present practical solutions to two complex analytical challenges.

Polysorbate 80 (PS80) is used to stabilize protein therapeutics in many pharmaceutical formulations including parenteral, ophthalmic, oral and topical preparations. However, PS80 is one of the most challenging solvents in extractables and leachable analysis. In this presentation, we will discuss issues with this solvent and provide some strategies that have been developed using the Agilent LC-TOF and associated analysis software packages.

You will also learn about an extractables study and a subsequent simulation study conducted on multilayer IV bags. These bags are used for packaging sterile water for injection and glycine buffer solution. The extracts in both studies were directly analyzed on an Agilent Q-TOF LC/MS for characterization of non-volatile compounds. The sensitivity and mass accuracy of the instrument allowed identification of compounds at hundreds of ppb (ng/mL) levels. Identification of compounds was facilitated by Agilent E&L database and library. Non-volatile extractables detected in the simulation study can be rationally correlated to those observed in the extractables study.

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Key Learning Objectives:

 

• Basics of Extractables and Leachables analysis

• A practical approach for E&L analysis of pharmaceutical products formulated with Polysorbate 80

• An approach using the Agilent 6550A iFunnel Q-TOF LC/MS to characterize non-volatile compounds at ng/mL levels

• Use of the Agilent E&L database and library to identify compounds in an E&L study

Who Should Attend:

 

• Pharmaceutical QC analysts and QC Lab Managers

• Researchers interested in Leachables Testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CRO's/CMO's and other

• Quality Assurance experts in above industries

 

Speakers

 
Michelle Kolodziejski, MS,
Principal Chemist,
Eurofins Lancaster Laboratories, INC
Eric Hill, MS,
Director Extractables and Leachables Services,
Boston Analytical
 

Moderator

 
Britt Erikson,
Senior Editor,
C&EN
 

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