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Material characterization is an important part of the selection process of containment/delivery systems for parenteral drug products.
A key aspect of material characterization is understanding extractable elements as potential leachables - an aspect that has gained more attention recently, resulting from the publication of new guidance documents:
These guidances provide clear direction for testing for elemental impurities in drug products, API’s and excipients. However, no clear guidance exists for examining elemental impurities in containment/delivery systems. This issue was addressed in the recent webinar (see it here):
Elemental Impurities: Change is Coming - Are You Ready?
In this webinar, a key part of the discussion centered on the experimental aspect of examining for elemental impurities - in particular extraction solvent selection. Historically, extraction solvents have included purified water, pH adjusted water, water/solvent mixtures, dilute acids, salt solutions, solutions with surfactants or chelating agents, and specifically-tailored solvent systems. These may not be ideal when the goal is to establish a baseline profile of extractable elements. In selecting the right solvent system, consideration must be given to the following points, to match with analytical capabilities, and ensure suitability of resultant data:
Material characterization is essential to selecting the right containment/delivery system for a drug product. West’s Analytical Laboratory has a staff of scientists who can design and execute studies in this area, and state-of-the-art facilities to support those studies. For more information, contact a Technical Customer Service (TCS) representative or account manager.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.