Quality & Testing
Every lot earns its CoA.
LEVEL's quality architecture is built around a single principle: trust is earned through data, not asserted through claims.
Release specifications
What every lot must meet
Testing process
From synthesis to your lab
Synthesis & Upstream QC
Each peptide is synthesised using solid-phase peptide synthesis (SPPS) with Fmoc chemistry. In-process analytical checks verify coupling efficiency at each elongation step before proceeding.
Crude Assessment
Post-cleavage crude product is assessed by analytical HPLC and LC-MS to confirm the presence of the correct molecular species and approximate yield before purification is initiated.
Preparative Purification
Reversed-phase preparative HPLC purifies the crude peptide to 98%+ target purity. Fraction analysis guides collection windows to maximise yield within specification.
Identity Confirmation (MS)
Purified fractions are confirmed by high-resolution mass spectrometry (LC-HRMS). The observed molecular ion is compared to the theoretical mass with <5 ppm tolerance required for release.
Purity Quantification (HPLC)
Final purity is quantified by analytical RP-HPLC with UV detection at 220 nm. A purity ≥98% is required for lot release. The HPLC trace is included in the Certificate of Analysis.
Endotoxin Testing
Each lot is tested for bacterial endotoxins using the Limulus Amebocyte Lysate (LAL) kinetic turbidimetric method. Results are reported in EU/mg on the CoA.
Third-Party Verification
Select lots undergo independent verification at an ISO/IEC 17025-accredited external laboratory. Third-party reports are available to Lab Partner members on request.
Lyophilisation & Packaging
Verified lots are lyophilised under controlled conditions to produce a stable, free-flowing powder. Vials are sealed under nitrogen and stored at −20 °C until dispatch.
Certificate of Analysis
What’s in your CoA
Every LEVEL order is accompanied by a lot-specific Certificate of Analysis. Unlike generic product CoAs, each document is tied to the exact production lot that was shipped to you.
- ◈ Lot number and manufacture date
- ◈ HPLC purity trace with % area result
- ◈ Mass spectrometry identity confirmation
- ◈ Endotoxin result (LAL method)
- ◈ Residual solvent data where applicable
- ◈ Storage and handling recommendations
- ◈ Third-party laboratory stamp and signatory