Method Development and Optimization
AMPAC Analytical provides full service method development for our customers based on decades of industry experience. From initial research including separation mode selection, stationary phase selection, mobile phase selection through to lifecycle method improvements, we work closely with customers to produce methods which meet or exceed their analytical needs. We specialize in various forms of LC and GC method development, but also provide adept wet chemistry, spectroscopic, microbiological, X-ray diffraction, and particle size method development services.
AMPAC Analytical applies our extensive chiral chromatography development experience to meet the challenges of complex chiral separations. We can help you develop robust normal and reversed phase chiral separations.
Forced Degradation Studies
As a part of formulation development, packaging selection, method development, or method validation, AMPAC Analytical provides rapid forced degradation evaluations for drug substance and drug product. Stress testing is a requirement of ICH and enforced through FDA audits. Based on the structure of the API and/or formulation components, we apply multiple degradation conditions to evaluate hydrolysis, oxidation, thermo-stability, and photolysis of the drug substance and drug product. These studies are used to screen degradation mechanisms and develop stability indicating methods. AMPAC Analytical applies advanced spectroscopic and chromatographic techniques, including NMR and LC-MS, to aid in structural elucidation of degradation products and to confirm degradation pathways.