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