Quality Control
Every Helix Therapeutics peptide is backed by rigorous analytical testing and complete documentation. Quality is not optional — it is foundational.
Quality Built In, Not Tested In
We apply quality principles at every stage of synthesis, purification, and analysis — not just at final release. Our four-phase QC framework ensures complete confidence in every batch.
Synthesis Monitoring
During SPPS, resin loading efficiency is confirmed by Fmoc UV deprotection monitoring. Coupling completeness is verified by Kaiser or chloranil tests after each amino acid addition. Cleavage cocktail composition and reaction time are documented in the electronic batch record. Crude peptide mass confirmation by analytical HPLC and ESI-MS is performed before proceeding to purification.
HPLC Fraction Analysis
All preparative HPLC fractions are analysed by analytical HPLC (C18, 5 µm, 250×4.6 mm) and ESI-MS before pooling. Only fractions meeting purity specifications are combined. UV peak area purity is calculated at 220 nm. For GMP batches, each HPLC column is qualified and within its validated lifetime.
Certificate of Analysis Parameters
All standard peptides are released against the following specification panel: Appearance (visual), Purity by HPLC (≥95% or per order specification), Identity by ESI-MS (monoisotopic mass ±0.5 Da), Peptide content by AAA (≥80% unless specified), Moisture content by Karl Fischer titration (<8%), and Bioburden (for sterile-grade products). Each CoA is signed by a QC manager.
Post-Release Integrity
Lyophilised peptides are stored at −20°C under nitrogen atmosphere in our qualified cold-store until dispatch. Stability programmes are run per ICH Q1A guidelines for GMP products. Retest dates are assigned and communicated on the CoA. Temperature-sensitive shipments include validated cold-chain packaging with data loggers.
Our Quality Framework
ISO 9001:2015
Our quality management system is certified to ISO 9001:2015 by Bureau Veritas, covering design, synthesis, purification, analysis, and distribution of peptide products.
ICH Q7 GMP
GMP manufacturing for clinical APIs follows ICH Q7 guidelines. Facility qualifications (IQ/OQ/PQ), process validation, and cleaning validation are maintained and current.
21 CFR Part 11
Our electronic batch record system is validated under 21 CFR Part 11 for audit trail integrity, electronic signatures, and data traceability for FDA-regulated projects.
USP / EP Compliance
Methods are developed and validated against USP and European Pharmacopoeia general chapters for HPLC, amino acid analysis, and water determination as applicable.
ISO 14001
Environmental management system certification confirms our commitment to minimising the environmental impact of our operations, including solvent recovery and waste reduction.
Client Audits
We welcome quality audits from pharmaceutical clients. Our QA team supports pre-audit questionnaires, on-site inspections, and post-audit corrective action planning.
What's Included With Every Order
| Document | Included | Notes |
|---|---|---|
| Certificate of Analysis (CoA) | Standard | Purity, identity, appearance, peptide content, moisture |
| HPLC Chromatogram | Standard | Analytical HPLC trace at 220 nm and 254 nm |
| Mass Spectrum | Standard | ESI-MS with observed and calculated MW |
| Safety Data Sheet (SDS) | Standard | GHS-compliant, available in EN / ES / FR |
| Amino Acid Analysis Report | On Request | Hydrolysis-based composition confirmation |
| Endotoxin Test Report | On Request | LAL test, <1 EU/mg specification |
| Sterility Test Report | GMP only | Per USP <71> for sterile-grade products |
| Full Batch Record Copy | GMP only | On QA approval, provided under CDA |