Endotoxin内毒素
An endotoxin is a toxin present in the outer membrane of certain bacteria that can cause fever or severe reactions when introduced into the body, and is a critical control for sterile and parenteral products. In translation, it appears in product specifications, release test methods, and contamination control documentation where limits are expressed in units per volume or per device.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Endotoxin appears in pharmacopoeial test methods, product specifications, batch release documentation, and process validation reports for injectables, implants, and dialysis products. Translators must accurately convey endotoxin limits, test types such as LAL, sample preparation steps, and depyrogenation procedures without implying different acceptance thresholds.
Translation checks
A common problem is mishandling units such as EU/mL, EU per device, or ng/mL and incorrectly rounding limit values, which can shift a product from compliant to noncompliant. Confusing endotoxin with exotoxin or pyrogen is another error. In specifications, these small wording changes may affect release decisions and patient safety.
Chinese document application
Endotoxin in context · laboratory report
- English source
- Report the endotoxin result in the specified unit.
- Chinese rendering to review
- 按规定单位报告内毒素结果。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
An endotoxin result is not interchangeable with a general microbial count. Preserve the method reference, unit and any qualifier such as below a reporting limit. Do not convert a qualified result into a precise value or infer a product acceptance decision.
Check the returned Chinese file
Compare the Chinese result qualifier with the source report legend. Preserve signs and reporting units together, and do not replace a below-limit or qualified result with an unqualified numerical entry in the return file.
Prepare the connected files
Provide the laboratory method and report template with units. Identify protected symbols and qualifiers that must be retained in the editable Chinese file.
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
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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.
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.