An impurity is any unintended chemical or biological substance present in a drug substance or finished product that originates from starting materials, intermediates, excipients, degradation, leaching, or contamination. In regulatory translation, the term appears in quality specifications, stability reports, analytical method validation, and the chemistry, manufacturing, and controls sections of dossiers, where known, unknown, and degradation-related impurities are identified, quantified, and limited.
Impurity appears in specification tables, stability reports, analytical method validation, and regulatory dossiers, particularly the chemistry, manufacturing, and controls sections. Translators encounter phrases such as specified impurity, unspecified impurity, total impurities, degradation product, and residual solvent when localizing quality documents, release certificates, product information, and regulatory correspondence for international submissions.
A frequent error is translating impurity as 'contamination' or 'pollutant,' which suggests an uncontrolled failure. Many impurities are known and have specified limits. Using the wrong term may make labels alarming or blur distinctions between specified, unspecified, and residual solvent categories, which can create review and compliance questions.
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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