Scope. This guide helps readers assess an analytical document. It does not certify any BEL product or replace verification with the issuing laboratory.

Identity and purity answer different questions

Identity asks whether the observed signal matches the expected substance. Purity describes the relative share of the main signal under the method used. A high purity result therefore does not, by itself, prove that the substance has the correct identity.

Liquid chromatography can separate and quantify detectable components. Mass spectrometry provides information about molecular mass. Different claims often require complementary methods.

Checkpoint. ‘99%’ without a method, chromatogram and identity check is incomplete information.

Read the method and its limits

A strong report identifies the instrument, method, essential conditions and calculation approach. It should distinguish sampling, analysis and issue dates.

Analytical validation considers characteristics such as specificity, accuracy, precision and relevant range. Not all validation detail appears on a COA, but the laboratory should be able to explain what the method actually measures.

What a purity COA does not prove

An identity or purity test does not automatically demonstrate sterility, absence of endotoxins, water content, residual solvents, stability or the total quantity in a vial. Each requires an appropriate method.

Compare commercial claims with the analyses actually performed. A document should never be given a broader meaning than the tests it reports.

  • Substance identity
  • Chromatographic purity
  • Actual quantity or content
  • Sterility and endotoxins
  • Stability during storage

Verify authenticity

The report should identify the laboratory, carry a traceable reference and ideally offer direct confirmation. Metadata, signatures or verification codes can help, but polished design cannot replace confirmation from the issuer.

BEL will publish a document only when it can be connected to a batch and displayed without misleading alteration. Missing documentation will remain marked as missing.