Uncompromising Quality Standards
Every compound produced by LyoGenix Labs undergoes rigorous multi-stage quality testing to ensure pharmaceutical-grade purity and consistency.
Our QA/QC Process
Quality assurance at LyoGenix Labs is not an afterthought — it is embedded into every stage of our manufacturing process. From raw material inspection through final product release, multiple checkpoints ensure that every batch meets our stringent specifications.
Our quality control laboratory is equipped with state-of-the-art analytical instruments, operated by experienced chemists with deep expertise in peptide characterization. Every batch undergoes a minimum of three independent analytical tests before release.
We maintain comprehensive batch records, stability data, and analytical documentation in accordance with GMP guidelines. Full traceability from raw materials to finished product is maintained for every batch produced.
Raw Material Testing
Identity and purity verification of all starting materials and amino acids before synthesis begins.
In-Process Controls
Monitoring at critical process steps including coupling efficiency, cleavage yields, and intermediate purity.
Final Product Analysis
Comprehensive testing suite including HPLC, MS, appearance, solubility, and moisture content.
Stability Monitoring
Ongoing stability studies under recommended storage conditions to verify shelf life claims.
High-Performance Liquid Chromatography
HPLC is the gold standard for peptide purity analysis. Our reversed-phase HPLC systems separate peptide mixtures based on hydrophobicity, allowing precise quantification of the target peptide and identification of any impurities.
Each batch is analyzed using validated methods with UV detection at 214 nm and 280 nm. We use C18 analytical columns with gradient elution to achieve optimal resolution of closely related peptide species.
Our minimum purity specification of ≥98% (by area normalization) ensures that researchers receive compounds of the highest quality, with impurity profiles well below levels that could affect experimental results.
Representative HPLC chromatogram — ≥98% purity
Mass Spec Verification Includes:
- Molecular weight confirmation (±0.1 Da accuracy)
- Isotope pattern analysis for elemental composition verification
- Fragmentation analysis for sequence confirmation
- Detection of modifications, deletions, or truncations
- Identification of synthesis-related impurities
Identity Confirmation by MS
Mass spectrometry provides definitive molecular identity confirmation for every peptide batch. Our ESI-MS (Electrospray Ionization Mass Spectrometry) systems accurately determine the molecular weight of each peptide, confirming that the correct sequence was synthesized.
This orthogonal analytical technique complements HPLC purity data by verifying molecular identity — ensuring that the major HPLC peak corresponds to the intended peptide target rather than a co-eluting impurity of similar hydrophobicity.
Certificates of Analysis
Every batch we release is accompanied by a comprehensive Certificate of Analysis (CoA) documenting all analytical results. CoAs are available upon request for any product and batch number.
HPLC Purity
Area% purity with chromatogram reference
MS Confirmation
Observed vs. theoretical molecular weight
Physical Properties
Appearance, solubility, moisture content
Third-Party Testing Commitment
In addition to our comprehensive in-house testing, we are committed to transparency and independent verification. We partner with accredited third-party laboratories for periodic independent analysis of our products, providing an additional layer of quality assurance for our customers.