Quality & Testing
How compounds are tested and documented
Two independent analytical methods establish what is in every lot: reversed-phase HPLC for purity, and mass spectrometry for identity. Results are compiled into a lot specific Certificate of Analysis before release.
HPLC purity testing
Reversed-phase high-performance liquid chromatography separates a sample by hydrophobicity. The area under the main peak, measured at 220 nm, is reported as percent purity against the total integrated peak area. This is the figure printed on the spec sheet and Certificate of Analysis for each compound.
LC-MS identity confirmation
Liquid chromatography–mass spectrometry confirms the observed mass of the main component against the expected molecular weight for the compound, verifying identity independent of the purity measurement.
Reading a Certificate of Analysis
Every Certificate of Analysis (COA) is tied to a specific lot number, not a compound in general. A sample COA layout is shown below. the fields match what you will see on any product's downloadable COA.
| Lot number | Unique identifier for the manufactured batch. Always cross-check this against the lot printed on your vial label before use. |
|---|---|
| Molecular formula & weight | The expected chemical identity, used as the reference point for the LC-MS result. |
| Appearance | Visual inspection result. confirms the lyophilized powder matches the expected physical description. |
| Purity (RP-HPLC) | Reported purity percentage against the minimum specification for that compound. |
| Identity (LC-MS) | Pass/fail result confirming observed mass matches expected molecular weight. |
| Storage condition tested | The storage condition under which stability data for that lot was generated. |
A sample layout is used above for illustration. Actual, lot specific COAs are available for download from each compound's spec sheet.
HPLC and LC-MS testing establishes chemical purity and identity only. It does not establish sterility, pharmaceutical grade, or suitability for any human or veterinary use. Synthesis Labs compounds are not manufactured, tested, or released under pharmaceutical Good Manufacturing Practice (GMP), and are not USP-grade articles.