In support of our impurities analysis, covering nitrosamine drug substance related impurities (NDSRIs) and various other extractable and leachable impurities, Emery Pharma offers expertise in designing synthetic strategies. Through our network of trusted subcontractors and specialized synthesis facilities, we produce the reference standards and small scale impurities needed to support and enhance our advanced analytical chemistry capabilities.
Emery Pharma also has expertise in reference standard synthesis, specialized impurity synthesis, and qualifying those reference standards in accordance with FDA and ICH guidance. Our team ensures proper characterization using qualified mass spectrometry, qualified nuclear magnetic resonance (NMR) spectroscopy, and other validated techniques, and can issue certificates of analysis for these impurities.
