At PharmaBlock, our analytical development and QC teams provide full spectrum services in analytical development, method validation, release testing and stability study from drug substance to drug product.
• Fit for purpose method development, validation and transfer, including stability-indicating method development and forced degradation studies
• RM control, IPC and API/DP release (chemical and physical property)
• Impurity profiling, impurity isolation and structural identification
• Reference standard characterization and qualification
• Specification establishment for early and late phase RM, intermediates and API/DP
• Internal method database for genotoxic impurities (GTIs)
• Informal and ICH stability studies