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Analytical Development & Quality Control

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