Purity & COAs

A certificate of analysis summarizes selected tests for a stated sample or batch.

• Useful records identify the batch, test method, laboratory, test date, result, and acceptance criteria.
• A document without traceable sample and laboratory details provides limited verification.

Chromatographic purity and molecular identity answer different questions.

• HPLC can estimate the relative abundance of detected components under stated conditions.
• Mass spectrometry can support molecular identity, but neither result alone establishes sterility, endotoxin status, concentration, or suitability.

Purity percentages should be interpreted with the method, chromatogram, sample preparation, and reporting limits.

• Third-party testing is most useful when the laboratory and submitted sample can be independently connected to the reported batch.
• Analytical documentation supports evaluation but is not standalone proof of safety.