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Read a certificate of analysis critically

Jillian Foglesong Stabile, MD

Jillian Foglesong Stabile, MD, FAAFP, DABOM

Sipra Medical Reviewer

  • American Board of Family Medicine
  • American Board of Obesity Medicine
  • Wake Forest University School of Medicine

ReviewsPatient-facing health education

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FAAFP, DABOM · Medical reviewer of record · Updated September 14, 2026 · September 14, 2026

Read a certificate of analysis critically

Use this checklist to identify missing context in a laboratory report. A certificate of analysis is not FDA approval or permission to use a research chemical in a person.

Entries stay in this page and disappear when you clear or reload it. Downloads and printouts remain wherever you save them. Avoid names, birth dates, member IDs and other identifiers.

A worked example

Fictional example, not personal medical information

Report or sample reference (optional)
Example report (fictional)
Marked complete by you
Identify who issued the report and confirm it directly through independently obtained contact details.
Still to check
Check what sample or lot was actually tested and whether it matches the claimed product.

The example shows the output format. Use your own verified information and take unresolved questions to the appropriate professional.

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Using this tool

Turn your entries into a useful record

Use this checklist to identify missing context in a laboratory report. A certificate of analysis is not FDA approval or permission to use a research chemical in a person. Entries are assembled into a downloadable worksheet. Marking a check complete records your own action; it does not certify a medicine, pharmacy or document.
This worksheet organizes information for a conversation. It does not verify a prescription, choose treatment or assess safety.
Read the stated scope
A certificate reports results for an identified sample, methods and acceptance criteria. Check whether the lot, date and test named on the report match what someone is claiming the document proves.
Before you finish

One result does not answer every quality question

CheckWhat to capture
Identity or assayWhat the named method found in the tested sample
Sterility or endotoxinSeparate testing with its own method, sample and limits
Clinical suitabilityNot established by a certificate of analysis
This page keeps entered details in browser memory. It does not email them or save them to your account. Clear or reload the page to remove the entries. Downloaded files and printouts remain under your control.
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Sources

  1. FDA component testing and supplier analysis controls www.fda.gov
  2. FDA production, process and sterility testing controls www.fda.gov
This worksheet organizes information for a conversation. It does not verify a prescription, choose treatment or assess safety. Medical reviewer of record: Jillian Foglesong Stabile, MD, FAAFP, DABOM. Updated September 14, 2026. Sources checked September 14, 2026.
Compounded medications are not FDA-approved and require a patient-specific prescription. Brand names are trademarks of their owners; sipra is not affiliated with them.