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