Quality Control & Standards

Quality Control & Standards

How every lot is tested, what it has to pass, and how we document it. Transparency on QC is part of what the eterna mark stands for.

1. Overview

Every lot we release is tested for identity, purity, and safety-relevant parameters before it ships. Material that fails any acceptance criterion is not released for sale. Our quality system is maintained as a documented quality management system with controlled batch records, standard operating procedures, and per-lot release testing.

2. Test methods

  • Purity — HPLC: reversed-phase high-performance liquid chromatography (RP-HPLC) with UV detection and gradient elution quantifies main-peak purity.
  • Identity — Mass spectrometry: ESI-MS confirms molecular weight against theoretical value.
  • Endotoxin: LAL testing where applicable for the material class.
  • Appearance & fill: visual inspection and fill-weight checks.

3. Acceptance criteria

  • HPLC main-peak purity: ≥ 99%
  • Mass accuracy: within ±0.5 Da of theoretical MW.
  • Endotoxin: < 0.5 EU/mg where tested.

These are the targets used in our process; the authoritative measured values for any specific lot appear on its Certificate of Analysis.

4. Certificate of Analysis

Each lot ships with a numbered Certificate of Analysis containing the HPLC chromatogram, mass-spec report, endotoxin result where applicable, storage guidance, and analyst sign-off. Browse and download CoAs on the Certificates of Analysis page.

5. Documentation & archive

Batch records and CoAs are versioned and archived for 5 years. You can request a past lot’s CoA by emailing us the lot number.

6. Independent verification

Where third-party verification is performed, it is conducted by an independent analytical laboratory, which is identified on the applicable Certificate of Analysis for that lot.

7. Scope & limits of testing

QC testing establishes chemical identity and purity of research materials only. It does not establish, and is not intended to establish, safety, efficacy, or suitability for use in or on humans or animals. All products remain research use only.

8. Questions

QC or documentation questions: [email protected].