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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.

•  Analytical method development, validation and transfer in comply with ICH guidelines

•  In process control and release testing in comply with GMP requirement

•  Forced degradation (stress) study for the detection of impurities or degradation products

•  Stability studies under varied temperatures and humilities per ICH guidelines

•  Impurity isolation and identification using prep-HPLC, LC-MS, GC-MS, FT-IR and NMR spectroscopy

•  Genotoxic and elemental impurity method development and validation

•  Reference standards characterization and qualification

•  Microbial limit testing