Impurity杂质
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.
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Where this term appears
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.
Translation checks
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.
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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