Analytical Development

Formurex’s Analytical and QC scientists bring deep technical expertise, extensive experience, and access to state-of-the-art instrumentation in both R&D and cGMP settings. They perform method development and validation, cGMP testing and release, as well as stability studies for in-process and finished products. Formurex is also equipped to handle controlled substances (Class II to Class V) and potent compounds with full compliance and care.

• 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 leachables testing studies
• Sample preparation procedure development, including filter compatibility and sample extraction recovery studies
• pH-solubility and 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 biological/synthetic membranes using Franz diffusion cells
• Discriminatory dissolution method development for immediate-release and modified-release dosage forms
• Temperature excursion studies for shipping