Formulation Development, DS/DP Stability and Analytical CMC Assays

BRI offers a variety of analytical chemistry assays supporting API/clinical product quality control and IND-enabling stability studies conducted in conformance to GMP and ICH requirements.

QUALITY CONTROL

IND-Enabling API / Clinical Product Quality Control Assays

– Manufacturing specification release assays
– Complementary LC/MS, HPLC and GC assays in support of specification release and QC testing
– Established USP drug product and drug substance monograph assays

STABILITY

Drug Substance and Drug Product Stability Studies

– Characterization and identification of unknown impurity and degradation product
– Impurities and degradation products assays by HPLC/UV/MS assay
– Product stress and stability studies under ICH stability protocols

Formulation Development

– Oral bioavailability enhancement
– pH-Dissolution, Disintegration in vitro-in vivo correlation
– Drug-excipient compatibility, chemical stability and physiochemical characterization
– Parenteral formulation stability