What the method does
Liquid chromatography separates components over time. Mass spectrometry measures their mass-to-charge signals. The laboratory interprets those data against the expected material and the method used.
What to ask the laboratory
- What was tested and how was the sample identified?
- What evidence supports the reported identity?
- What does the method distinguish, and what are its limitations?
- Are the relevant spectra and chromatograms available?
Separate the questions
| Question | Evidence to review |
|---|---|
| Identity | The laboratory's identity method and supporting data |
| Chromatographic purity | The stated method, result and trace |
| Measured vial content | A content assay with units and a sampling basis |
| Endotoxin or microbial findings | The separate tests actually performed |
| Sterility | A separate sterility assessment, not an LC-MS identity result |