From Synthesis to
Shipment
The full quality chain — how every Helixera compound is sourced, tested, stored, and verified before it reaches a research lab.
Acceptance Criteria
The Quality Chain
Quality in research peptides isn't a single test — it's a chain of decisions from synthesis through to delivery. A peptide can be synthesized correctly and then degraded by poor storage, contaminated by poor handling, or misdosed by inaccurate water content measurement. We control for each of these specifically.
Synthesis — GMP-Aligned Facilities
All compounds are synthesized at GMP-aligned facilities using solid-phase peptide synthesis (SPPS) — the industry standard for research-grade peptide production. Synthesis batch records are maintained and available on request.
Purification — Preparative HPLC
Raw synthesis output contains truncated sequences, deletion peptides, and protecting group residuals. Preparative HPLC purification isolates the target peptide from these impurities, achieving ≥98% purity before lyophilization.
Lyophilization — Freeze-Drying
Purified peptide in solution is freeze-dried to produce the stable lyophilized powder. The lyophilization cycle is validated to minimize residual water while preserving peptide structure.
Third-Party Testing
Every batch is sent to an independent laboratory for: HPLC purity, MS identity confirmation, Karl Fischer water content, endotoxin testing, and residual solvent analysis. Testing is completed before the batch is released.
Helixera Receipt Verification
We verify the COA against our own internal acceptance criteria before adding any batch to inventory. Batches that don't meet specification are rejected — not discounted and sold.
Storage in Controlled Conditions
Inventory is stored refrigerated or frozen per compound-specific requirements. Temperature logs are maintained. Cold chain is preserved through to packaging.
Packaging & Shipment
Orders are packaged with desiccant and appropriate insulation. Temperature-sensitive compounds ship with cold packs where transit time requires it. Vials are labeled with batch number matching the COA.
Test Parameters & Acceptance Criteria
| Test | Method | Acceptance Criterion |
|---|---|---|
| Purity | Reverse-phase HPLC | ≥98.0% |
| Identity | ESI-MS or MALDI-TOF mass spectrometry | Measured MW within ±1 Da of theoretical |
| Water Content | Karl Fischer titration | Reported; typically ≤8% |
| Endotoxins | LAL chromogenic assay | <10 EU/mg |
| Residual Solvents | Gas chromatography (GC-MS) | Within ICH Q3C limits |
| Appearance | Visual inspection | White to off-white lyophilized powder |
Batch Traceability
Every vial shipped from Helixera Labs has a batch number on the label. That batch number links directly to:
Certificate of Analysis
The full third-party lab report showing all test results for that specific batch — purity, identity, water content, endotoxins, solvents.
Synthesis Record
The facility and synthesis run that produced the batch. Available to institutional researchers on request for audit purposes.
Storage Log
Temperature and storage condition records from receipt through to shipment. Ensures cold chain integrity for temperature-sensitive compounds.
To request a COA for any batch, email info@helixeralabs.com with the batch number from your vial label. COAs are provided at no charge.
What Makes a Batch Fail?
Rejected batches are not uncommon in peptide manufacturing. Common failure modes we screen for:
Questions about a specific batch?
We'll send you the full COA with all test results.