Identity

Mass evidence asks whether observed ions support the expected molecular mass. It is different from chromatographic purity.

Purity

HPLC estimates the proportion of the detected chromatographic response associated with the principal peak under the stated method.

Quantity

Content requires a calibrated measurement and traceable sample preparation. Peak-area percentage alone does not establish milligrams per vial.

Traceability

A useful report links the submitted sample, preparation, analytical run, result, issue date and revision.

Raw evidence

Chromatograms and spectra should be sample-specific, legible and consistent with the reported result.

Limits

Identity and purity do not demonstrate sterility, endotoxin level, biological activity or clinical safety.