Proof behind every lot.
Quality systems, regulatory support and in-house analytics that apply across peptides, oligonucleotides, resins, impurities and small molecules.
Quality Systems
Quality Management
Documented procedures for batch records, deviations, CAPA and change control across every product line.
Supplier Qualification
Raw materials, resins and building blocks sourced from qualified suppliers with incoming QC.
Traceability
Lot-level traceability from starting materials to final release, retained samples for every batch.
Regulatory Support
Regulatory Documentation
Support for DMF, IND and CTD Module 3 sections for peptides, oligos and small molecules.
Impurity Profiling
Identification and qualification of impurities in line with ICH Q3A/Q3B and peptide-specific guidance.
Nitrosamine Risk Assessment
NDSRI evaluation and reference standards to support nitrosamine risk assessments.
Analytical Capabilities
Chromatography
- HPLC / UPLC (UV, PDA)
- Chiral HPLC
- GC and GC-headspace
- Ion chromatography
Mass Spectrometry
- LC-MS and LC-MS/MS
- High-resolution MS
- MALDI-TOF for peptides
Spectroscopy
- 1H and 13C NMR
- 2D NMR (COSY, HSQC, NOESY)
- FTIR
- UV-Vis
Physicochemical
- Karl Fischer water content
- TGA / DSC
- Amino acid analysis
- Peptide content and counter-ion
Certificate of Analysis
Every lot ships with a certificate of analysis. Method summaries, stability data and spectra are available on request.
Request a sample COA- 01Identity: 1H NMR, mass spectrum, IR
- 02Purity: HPLC chromatogram with integration
- 03Water content: Karl Fischer or TGA
- 04Residual solvents and sulphated ash, where applicable
- 05Assay on an as-is basis (titrimetry or mass balance)
- 06Storage conditions, retest date and lot number