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