API Impurity Isolation & Identification
ICH guidelines for Drug Substances and Drug Products require that related impurities and degradants in Active Pharmaceutical Ingredients (APIs) and Drug Products be structurally identified at certain threshold levels depending on dose. Our capabilities in separation science (analytical HPLC, LCMS, GCMS and preparative HPLC), spectroscopic methods (NMR, MS and IR) and our knowledge of chemistry give us an edge in cracking even the most difficult API impurity and degradant isolation and identification situations.
Features of Structure Elucidation Services at Novatia:
- Rapid Structure Profilng using LC/UV/MSn to quickly survey a sample and obtain exact mass, purity, and substructural information on relevant components in a sample.
- Targeted component isolation using Novatia’s sample purification and isolation methods to enable detailed structure studies including ion mapping and NMR analysis.
- Detailed structure analysis using Novatia’s MSn ion mapping for rapid localization of modification of parent structures and/or High Sensitivity NMR Analysis to obtain full 1D and 2D homo and heteronuclear NMR data for detailed structural information to answer questions such as site of attachment/modification on as little as fifty micrograms of sample.
- Experienced MS and NMR scientists and organic chemists with many years of pharmaceutical industry experience.
Contact us to get Novatia’s API impurity Isolation and Structure Elucidation team working for you.