Research compound testing: purity, identity and documentation

Identity versus purity

Identity testing asks whether the submitted sample corresponds to the expected compound. Chromatographic purity describes detector response attributed to the principal peak under the stated method. Content or assay testing asks how much analyte was measured in the tested sample.

These answers are complementary, not interchangeable. None establishes sterility, endotoxin status, safety, efficacy, or an unlisted result. Each conclusion should be limited to the sample, method, result, unit, and qualifications shown on the report.

Reversed-phase HPLC

High-performance liquid chromatography separates components before a detector records their responses. An area-percent result expresses one peak's share of the integrated response under that particular method and detector.

Area percent is not milligrams per vial or net content. Quantity requires a suitable assay or content method with an amount and unit. Method details and limitations matter because a percentage from one analytical procedure cannot be silently reinterpreted as a different measurement.

LC-MS identity confirmation

Liquid chromatography coupled to mass spectrometry can provide mass information about separated species. An observed value may be compared with an expected sequence or formula as part of an identity assessment.

The report should identify the sample, method, report or accession number, date, result, unit where applicable, and any interpretive limits. A date supplies context but does not validate or invalidate the report by itself.

Independent laboratory reports

Some batch records include an independent laboratory report, while others may include supplier internal quality-control documentation or a pending status. Supplier internal QC is not independent testing and must remain labelled according to its actual source.

An ATMI batch ID, supplier lot ID, and independent laboratory report or accession ID may differ. Users should follow the explicit mapping in their order documentation and ATMI batch record rather than expecting the strings to match or assuming an identifier appears on every vial.

What testing does not establish

A raw-material result does not establish the measured contents or sterility of each finished vial. Quantity or assay and microbial tests answer separate questions. Missing sterility, endotoxin, content, identity, or purity tests must never be inferred from another result.

Analytical testing does not establish human-use safety, efficacy, or suitability, and it does not change the research-use-only status of the compounds described on this site.

• View available batch documentation →
• Verify an ATMI batch →
• Read Purity vs. Content →