Extractables and Leachables可提取物与浸出物
Extractables and leachables are chemical species that can be released from a container closure system, device component, or packaging material. Extractables are compounds pulled from the material under laboratory stress conditions, while leachables are substances that actually migrate into the drug product under normal storage and use; both are assessed in safety and stability studies.
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Where this term appears
In translation and localization, extractables and leachables reports appear in regulatory submissions, toxicological risk assessments, and pharmaceutical development documents. Translators may handle test methods, compound names, analytical results, and compliance summaries for container and device materials across multiple jurisdictions.
Translation checks
A common error is translating “extractables” and “leachables” into the same target term, collapsing a critical distinction: extractables are potential leachables, not necessarily present in the drug product. Mislabeling a compound as a leachable can overstate patient exposure and trigger unnecessary toxicology review.
Keep the term aligned across your files
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Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
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Walvax Biotechnology
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Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
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