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.
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.
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.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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