Nitrosamine Impurity亚硝胺杂质
Nitrosamine impurities are a class of chemical compounds, some of which are potentially carcinogenic, that can form or be introduced in drug substances or products during manufacturing, storage, or through reactions with excipients and packaging components. In pharmaceutical quality documentation and regulatory submissions, they are addressed through risk assessments, validated analytical methods, and specified control limits that must be justified with stability and release data.
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Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Nitrosamine impurity content appears in drug substance specifications, analytical method validation reports, risk assessment narratives, stability study summaries, and deficiency responses. In eCTD Module 3 quality sections, translators must keep compound names, limits, and units precise, and preserve the difference between acceptable intake and measured levels while adapting regulatory terms to the target market.
Translation checks
A common error is mixing up specific nitrosamine names or translating “acceptable intake” with vague wording that loses the numeric limit. Another mistake is omitting units such as ng/day or converting them incorrectly, which can make a control limit appear far stricter or looser than intended during regulatory quality review.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
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
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
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.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.