The availability of new pharmaceutical products and their quality is a key value in the modern drug development industry. The crucial stages of the drug development process are the identification, quantitation, and control of pharmaceutical impurities. The quantity of unwanted compounds determines the overall safety of the final pharmaceutical product. The restrictions of the impurity content in active pharmaceutical ingredients (APIs) and drug formulations are provided in such compendia as USP, EP, BP, JP, and ChP.

Our Impurity Reference Standards Library includes 675 drug reference standards in the stock. The certificates of analysis are provided for all compounds: they include clear-cut identity and purity data validated using NMR, HPLC/MS, and/or GC/MS methods.

Related terms: Reference standard, Related compound, Impurity, Analytical standard