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.
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This worksheet organizes information for a conversation. It does not verify a prescription, choose treatment or assess safety.
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.
Run your own numbers in the tool above.
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
Check
What to capture
Identity or assay
What the named method found in the tested sample
Sterility or endotoxin
Separate testing with its own method, sample and limits
Clinical suitability
Not established by a certificate of analysis
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No. A report concerns a tested sample and specified methods. Identity or assay results do not establish every aspect of finished-product quality, sterility or clinical suitability. A certificate does not grant FDA approval or authorize human use of a research chemical.12
Yes. Download a text file or use Print / save as PDF. Entries stay in browser memory and are not emailed or saved to your Sipra account. Clearing or reloading the page removes them from the page, while files and printouts you saved remain under your control.
It links the stated test result to the sample described in the report. If the identifier is missing or does not match the claim being made, record that gap rather than assuming the result covers another lot.
No. Purity and sterility are different questions that require appropriate methods and acceptance criteria. Check which test was actually performed and what sample it covered.2
FDA component testing and supplier analysis controls www.fda.gov
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.
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