Our specialized impurity standards portfolio includes process-related impurities, degradation products, and unknown impurities essential for pharmaceutical analysis. We offer both known impurities listed in pharmacopoeias and custom-synthesized unknown impurities identified during stability studies. Our impurity standards support ICH Q3A and Q3B guideline compliance, helping pharmaceutical companies establish impurity limits and validate analytical methods.
Each impurity standard is provided with complete structural characterization using NMR, LC-MS, and other analytical techniques. We also offer impurity profiling services to help identify and characterize unknown degradation products, supporting forced degradation studies and stability-indicating method development.