Certificate of Analysis分析证书
A certificate of analysis is a quality documentation record issued by a manufacturer or a qualified testing laboratory that lists the test results for a specific batch or lot of material and confirms whether those results meet the approved specifications. In regulatory submissions and batch release, the CoA appears as a signed analytical document supporting drug substance, drug product, excipient, or device component quality.
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
In translation and localization, certificates of analysis appear in regulatory dossiers, import/export documentation, supplier qualification, and quality agreements. Translators may handle CoAs into multiple languages for customs, tender submissions, or manufacturing partners, and need to align test item names, methods, and limit units.
Translation checks
A frequent mistake is translating analytical method names literally or inconsistently, so a pharmacopoeial method such as “loss on drying” becomes confused with another procedure. Mixing decimal separators, units, or specification limits can also make the CoA appear out of specification and block batch release.
Chinese document application
Certificate of Analysis in context · analysis certificate
- English source
- Compare the result with the stated specification.
- Chinese rendering to review
- 将结果与规定的规格要求进行比较。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
A result, a specification and a disposition may be separate columns. Keep them on the same row without merging their meanings in Chinese. Preserve batch identifiers, test names, units and qualifiers. Do not add a pass statement where the source records only a value.
Check the returned Chinese file
Compare the source and Chinese versions of one complete analysis row. Confirm the test name, limit, actual result and any disposition remain separate, including where the original form contains blank or merged cells.
Prepare the connected files
Send the certificate layout and approved test terminology. Mark whether signature fields, company names and unchanged identifiers are protected in the return 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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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.