Finecure’s analytical research division underpins its regulatory success and registration-ready dossiers, providing analytical support across the full product lifecycle — from API characterisation to final commercial batch release.
Analytical research supports both formulation development and routine release. Chromatography and spectroscopy drive method development, impurity profiling and stability testing, with methods validated to ICH guidelines before they are used for release.
Stability programmes run to ICH conditions including Zone IVa and Zone IVb, which is what a buyer supplying tropical and high-humidity markets needs to see. For moisture-sensitive molecules — amoxicillin-clavulanate in particular — stability through shelf life is the property that decides whether a product is viable in those markets at all.
Data integrity across analytical systems is maintained to 21 CFR Part 11, with results logged, encrypted and audit-ready.
Our advanced analytical laboratories are equipped with the latest generation of testing infrastructure to guarantee molecular accuracy.
Finecure operates 24/7-monitored stability chambers for real-time and accelerated studies, following ICH guidelines across all climatic zones to validate shelf-life for global export markets.