Identification

Elucidating “Unknown Substances”

Chemical structure elucidation of unknown peaks: This might be metabolite profiling or identifying your impurities or degradation products (= impurities of drug product). Thorough knowledge about your own product (beyond your API itself) is increasingly demanded by the authorities and guidelines: Impurities, degradation products, side and byproducts (see Impurities & Degradation Products).