Start with the sample, not the purity number
A Certificate of Analysis reports findings for an identified sample. First match the compound, strength and full lot to the vial. If the laboratory uses a different sample number, the batch record must connect it to your lot.
Check the document itself
- Open the complete report, including footnotes and any continuation pages.
- Identify the issuing laboratory, report number, dates and revision.
- Use the laboratory’s official verification service where available.
- Read any qualifications about subcontracted work, scope or sample information.
A laboratory logo or QR code alone is not authentication. A QR code is only a link; inspect the destination and the record it opens.
Separate the result from the requirement
| Illustrative entry | How to read it |
|---|---|
| Quantity: 9 mg/vial | A measured amount; compare it with the labeled amount and criterion. |
| Purity specification: NLT 98% | A requirement of not less than 98%, not a measured result. |
| Purity result: 99% | The reported value on the named method’s basis. |
| Contaminant: ND | Not detected within the method’s stated scope and boundary. |
| Pending | No final finding is available. |
All numbers above are teaching examples. A pass/fail label is meaningful only alongside the requirement being applied.
Check units before comparing
mg/vial is an amount; mg/mL is a concentration. EU/mL describes endotoxin activity in a stated preparation; CFU describes recovered microbial growth. These units cannot be interchanged. “<1” without a unit and sample basis leaves the result incomplete.
For a blend, find amounts and identity evidence for each component. For multiple tested vials, determine whether the figures are individual results, an average or a pooled measurement.
What to ask when something is missing
A useful question is specific: “Which submitted sample corresponds to this lot?”, “What is the reporting limit?” or “Does this quantity describe each vial or an average?” Keep the original file and the answer with your order record.
A COA supports material assessment within its test scope. It does not establish clinical efficacy, a safe dose or suitability for administration. Laboratory competence is a separate question addressed by accreditation and scope. ISO: laboratory competence.
Sources
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