The NovaEvum standard / 01
Trust should be testable.
Anyone can print a number on a label. What matters is whether the number traces back to an instrument, a method, and a laboratory willing to put its name on the result.
Analysis / 02
- RP-HPLC
- Reversed-phase separation on a C18 column with UV detection at 220 nm. Purity is reported as integrated peak area against the total, to one decimal place.
- Mass spectrometry
- ESI-MS identity confirmation against the calculated monoisotopic mass for the stated molecular formula.
- Water content
- Karl Fischer titration on lyophilised material, reported as percentage by mass.
- Residual solvents
- Headspace GC, screened against the solvent set used in synthesis and purification.
Handling / 03
- Per-lot release
- Material is analysed per lot, never per batch family. A lot is not released without its own result on file, and the certificate names the laboratory that produced it.
- Cold chain
- Vials are held at -20 °C protected from light. Lyophilised material tolerates transit at ambient temperature and should be returned to -20 °C on arrival.
- Independent verification
- Analysis is carried out outside our own walls. A supplier grading its own material is not a control.
- Documentation
- The lot code printed on the vial resolves to the certificate for that lot. No averages, no substitutions.