Custom Synthesis & CRAMS
Custom Synthesis and CRAMS
Novel impurity synthesis, custom intermediates, forced degradation studies, and reference batch recreation. Regulated and research-grade outputs. FDA-referenced documentation with every deliverable.
Novel Impurity Synthesis
Unknown or hypothesised impurity structures synthesised from first principles. Identity confirmed via NMR (1H, 13C), LC-MS/HRMS, and FTIR before delivery. Used for method validation and ICH Q3A/B compliance.
Custom API Intermediates
Multi-step synthesis of intermediates not commercially available. Route scouting, optimisation, and scale-up from milligrams to kilograms. Full batch documentation available for commercial-scale runs.
Forced Degradation Studies
Systematic stress testing under ICH Q1B conditions (acid, base, oxidation, heat, light). Degradation products isolated, characterised, and supplied as reference standards for method development.
Reference Batch Recreation
Synthesis recreation of historical or discontinued reference batches for comparability, stability, and method transfer studies. Full batch documentation and COA.
What Is Included With Every Custom Deliverable
Confidentiality
All custom synthesis engagements are covered by a mutual NDA before any technical discussion. We do not disclose client structures, routes, or projects to any third party.
Available Materials
Novel Impurity Synthesis
Forced Degradation Studies
Need a custom grade, scale, or specification?
Most of our catalogue is also available as made-to-order at different purity, grade, or scale. Tell us your requirement and we will confirm availability within 24 hours.