How to read a Certificate of Analysis

What a COA is — and what it is not

A Certificate of Analysis is a record of results for the sample described on the document and the tests actually performed. The sample may be raw material, an intermediate, or a finished-vial sample; that distinction changes what the result can support.

A raw-material result does not establish the measured contents or sterility of each finished vial. A COA is not a safety assessment, approval, efficacy finding, or statement of suitability for human use.

The fields to check first

Before reading results, confirm the report actually corresponds to your material.

• Laboratory and sample description — identify who issued the result and what material was submitted.
• Report or accession number — identifies the laboratory record when one is available.
• Method, result, and unit — show the question asked and the form of the answer.
• Analysis or report date — provides chronology, but a date alone neither validates nor invalidates a report.
• Limitations or qualifications — define boundaries that must remain attached to the result.

Reading the analytical results

Chromatographic area-percent purity is the main peak's share of integrated detector response under the stated method. It is method- and detector-dependent. It is not milligrams per vial, net content, sterility, endotoxin status, safety, or efficacy.

Quantity or assay testing addresses amount, while microbial, sterility, or endotoxin testing addresses separate questions. If a test is not listed, its result cannot be inferred. Identity may be investigated by mass spectrometry or another stated method, but only the report's actual procedure and conclusion should be represented.

Matching a COA to the vial in hand

An ATMI internal batch ID, a supplier lot ID, and an independent laboratory report or accession ID can be different. They do not need to be identical strings, and this guide does not assume a batch ID is printed on every vial. Follow the explicit mapping supplied in the order documentation and displayed in the ATMI batch record.

Use the COA Library or Batch Verification page to retrieve that record. A supplier's internal quality-control document must remain identified as supplier documentation; it must not be described as independent testing. A report from another sample or batch is not a substitute.

Recording the result

A useful receiving record preserves the ATMI batch ID, any mapped supplier lot or independent report ID, sample description, laboratory, method, result, unit, date, and stated limitations when those fields are actually available. Keeping the identifiers distinct prevents an apparent text mismatch from being mistaken for either proof or disproof of traceability.

• View the COA Library →
• Verify an ATMI batch →
• Read Purity vs. Content →