Analytical R & D

Analytical R & D

Analytical R & D

Our analytical chemists provide comprehensive analytical testing support for process development and drug substance and drug product manufacturing. Our analytical team follows regulatory guidances on supply chain assurance for quality control. The analytical capabilities include platforms of excellence for the following:

Analytical method development, method validation and qualification

Analytical technology method transfer

Reference standard characterization and qualification

ICH stability studies for drug substance and drug product

Impurity identification, characterization and profiling

Genotoxic impurity method development and validation

cGMP batch release testing for drug substance and product and COAs

Process control strategies and analytical QC manufacturing supports

Formulation solubility, dissolution and disintegration studies

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