The Formurex Analytical and QC Scientists have the required technical expertise, experience, and state-of-the-art equipment in both R&D and cGMP environments to perform the method development and validation, cGMP testing & release, and stability of the in-process and finished products.
Formurex has the capability to work with controlled substances (Class II to Class V) and potent substances.
Analytical services for small and large molecules per ICH/USP guidelines.Method development, validation, and transfer, including assay, related substances, impurities, uniformity of dosage units, and dissolution for various developmental dosage forms and finished products (tablets, capsules, multi-particulates, liquids, gels, creams, and ointments).Raw materials (API and excipient) and finished product testing and release.Stability sample testing for developmental and clinical batches (GMP).Cleaning verification and validation studies, including method development and verification testing. Extractables and Leaching Testing Studies. Sample preparation procedure development, including filter compatibility and sample extraction recovery studies.pH-solubility & pH-stability profile testing at accelerated conditions.Viscosity and Osmolality testing.Particle Size analysis by laser diffraction(micron) and dynamic light scattering (submicron).Permeability and flux measurements of investigational compounds across the biological/synthetic membranes using Franz Diffusion cells.Discriminatory Dissolution method development for immediate release and modified-release dosage forms.Temperature Excursion Studies for shipping.
