Quality
Quality is not a tagline — it is a process, and a process leaves a record. Every batch is judged against criteria written before it existed, analysed by a party with nothing to gain from the answer, and released with a certificate anyone can check.
How every batch reaches you
Each depends on the one before it. A specification means nothing without independent testing; independent testing means nothing unless the result is published; publication means nothing unless the certificate names a batch you can identify in your own freezer.
01
Every batch begins under a written specification agreed before the first coupling — sequence, target purity, permitted impurity profile, residual solvent ceiling, and the analytical methods each will be judged by. Agreeing the criteria before the result exists is what stops the criteria being fitted to it.
02
Independent laboratories accredited to ISO/IEC 17025 establish identity and purity by HPLC and mass spectrometry. In-process testing informs manufacturing decisions; it does not release material. Keeping those two functions structurally separate is the point — we do not grade our own work.
03
A certificate of analysis is published for every batch, carrying an accession number the issuing laboratory can retrieve independently of us. Browse them all in the lab results library — no request, no login, no gate.
What every batch is judged against
A batch either meets it or it is rejected. There is no intermediate category, because an intermediate category is where standards erode quietly.
| Determination | Specification | Why it matters |
|---|---|---|
| Purity | ≥ 99.0% | Principal peak area by reversed-phase HPLC at 214 nm. |
| Identity | Conforms | Measured mass within tolerance of theoretical by ESI-MS. |
| Assayed content | 95.0 – 110.0% | Against nominal label strength, referenced to a standard. |
| Water content | ≤ 8.0% | Karl Fischer titration. Directly affects mass-based calculation. |
| Residual solvents | USP <467> | Headspace GC-FID against compendial limits. |
| Traceability | Batch-level | Vial label, certificate and retained sample share one identifier. |
Chain of verification
Every stage settles a question, and settles it before the next begins. Where a stage fails, the consequence is documented rather than absorbed.
Independent by structure
Two accredited laboratories are engaged, so no single analytical relationship becomes load-bearing. Neither has an ownership relationship with EVOHN or with the contracted manufacturing sites.
Verifying independently
Every certificate carries an accession number issued by the testing laboratory, retrievable from that laboratory directly — which is the point of publishing it. If you would like a report confirmed at source, the desk will arrange it rather than vouch for it.
Documentation
Certificates are published for every batch, current and superseded. Archived records and confirmation at source are both handled by the research desk.