Quality
How we work
We test to documented methods, verify every result and sign off each certificate of analysis.
Methods
- RP-HPLC-UV: reverse-phase high-performance liquid chromatography with UV detection, at 214 nm primary and 280 nm secondary wavelengths, for purity.
- LC–MS / ESI-MS: liquid chromatography with mass spectrometry (electrospray ionization) for molecular weight identity confirmation.
- LC-MS/MS: liquid chromatography with tandem mass spectrometry for impurity profiling and degradation product characterization.
- LAL assay: Limulus amebocyte lysate test for bacterial endotoxins.
The certificate of analysis
Each certificate of analysis gives the results for the tests you ordered, with the chromatogram and spectra behind them. Results relate only to the samples tested, as received.
Partner laboratories
Some testing may be performed by qualified partner laboratories. We review and verify partner results, and we sign off every certificate of analysis.
What we are not
- Not a clinical laboratory: we do not test human specimens for diagnosis.
- Not a regulator: a certificate of analysis describes the sample we tested; it is not a product approval.