Potency is a quantitative measure of the biological activity of a drug substance or finished product, determined by a validated analytical or bioassay and typically expressed as a percentage or activity unit relative to a reference standard. In pharmaceutical and biologics documentation, it appears in specifications, certificates of analysis, stability studies, batch release summaries, and regulatory submissions where clinical effect depends on a defined strength.
In translation and localization for pharmaceuticals and biologics, potency appears in specifications, certificates of analysis, stability tables, bioassay validation reports, batch records, and product labeling. Translators must be careful when handling units, decimal places, and acceptance criteria in documents such as method transfer protocols and regulatory dossiers where potency is a release parameter.
A common mistake is translating potency as 'effectiveness' or 'strength' in a way that blurs its status as an assay-based release criterion. In biologics, potency is often measured in activity units rather than mass; using a vague term may misstate acceptance limits and affect batch release wording.
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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