Conduct Extraction Studies on Rubber Closures to Ensure Container Compatibility
Understanding the Tip: Why rubber closure extraction studies are critical: Rubber closures—such as stoppers and septa—are commonly used in vials, ampoules, and injectable products stored in stability chambers. These elastomeric components can release extractables under heat, humidity, or solvent exposure, which may become leachables in the drug product. Performing extraction studies helps identify the profile…
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