Quality Control
Quality Control
Testing · Verification · Sourcing Standards
Our quality control programme defines the testing methodologies, acceptance criteria, sourcing standards, and release protocols that ensure every research compound meets the rigorous specifications required for credible scientific work.
Analytical Testing Methods
Six analytical methods form the foundation of our compound verification programme.
Reverse-Phase High-Performance Liquid Chromatography
Primary purity determination method
RP-HPLC separates compounds based on hydrophobicity, quantifying the percentage of the target compound peak area relative to all detected peaks. It identifies related impurities, synthesis by-products, and degradation products with high sensitivity.
Mass Spectrometry Identity Confirmation
Definitive identity verification
Electrospray ionisation (ESI-MS) or matrix-assisted laser desorption/ionisation (MALDI) mass spectrometry provides the molecular weight of the compound to within sub-dalton precision, confirming the identity of the compound is exactly as specified.
Limulus Amebocyte Lysate Endotoxin Test
Bacterial endotoxin detection
The LAL assay detects and quantifies bacterial endotoxins using lysate from horseshoe crab blood cells. Low endotoxin levels are essential for cell culture studies where endotoxin can activate TLR4 signalling and confound inflammatory assays.
Residual Solvent Analysis
Synthesis solvent detection
Gas chromatography (GC) with flame ionisation or mass spectrometry detection identifies and quantifies residual synthesis solvents including acetonitrile, DMF, TFA, DMSO, and methanol. Excess solvent residues can be cytotoxic and compromise research validity.
Microbial Limits Testing
Total viable count and pathogen testing
Microbial limits testing per USP Chapter <61> assesses total aerobic microbial count (TAMC) and total yeast and mould count (TYMC). USP <62> tests for specified pathogens including E. coli, Salmonella, and Staphylococcus aureus.
Appearance & Physical Characterisation
Visual inspection and solubility testing
Physical characterisation includes visual appearance assessment (colour, form, homogeneity), solubility testing in specified solvents, moisture content determination by Karl Fischer titration where relevant, and confirmation of lyophilisation quality.
Sourcing Standards
Our sourcing criteria establish minimum requirements for all synthesis facilities we work with. Supplier qualification is an ongoing process, not a one-time assessment.
GMP-Aligned Manufacturing
Synthesis facilities must operate to Good Manufacturing Practice (GMP) or GMP-aligned quality systems for research-grade compound production
In-Process Quality Controls
Synthesis facilities must maintain in-process quality controls including intermediate analysis, yield monitoring, and deprotection verification at key synthesis steps
Full Batch Documentation
Complete batch manufacturing records, raw material specifications, and synthesis routes must be maintained and available for audit on request
Controlled Access & Security
Facilities must have controlled access, appropriate environmental monitoring, and secure compound storage and handling procedures in place
Regulatory Compliance
All manufacturing and supply operations must comply with applicable national and international regulatory requirements for research chemical production and export
Batch Release Process
Synthesis
Solid-phase peptide synthesis at qualified facility with in-process controls
Testing
Independent analytical lab conducts HPLC, MS, LAL, residual solvents, and microbial testing
Review
Test results reviewed against all acceptance criteria — all tests must pass
CoA Issued
Certificate of Analysis generated with batch number and all verified analytical data
Release
Batch released to inventory — CoA filed and available on researcher request
Traceability & Documentation
Full documentation traceability from raw materials through to the researcher.
Batch Traceability
Every vial shipped carries a unique batch number that links to the full manufacturing and testing record for that specific batch. This enables researchers to verify the exact analytical data for the material they received.
Document Retention
Manufacturing records, raw material certificates, analytical data, and CoAs are retained for a minimum of 5 years. Researchers requiring historical documentation for publication or audit purposes may request records by contacting us with batch details.
Product Labelling
All products are labelled with compound name, batch number, mass/quantity, storage conditions, and research use only designation. Labels are designed to comply with GHS hazard communication and research chemical labelling requirements.
Continuous Improvement
Our quality control programme is subject to ongoing review. Test methods are updated in line with advances in analytical standards, and supplier qualification is reviewed regularly to ensure continued alignment with quality expectations.
Quality Assurance for Scientific Confidence
Our quality control programme exists to give researchers confidence in the materials they use and the data they generate. If you have questions about our testing methods, acceptance criteria, or sourcing standards, or if you require documentation for institutional compliance purposes, please contact our quality team.