The presence of Impurities in Active Pharmaceutical Ingredients (APIs) and Drug Products represents a tremendous risk to patients’ health. Unidentified impurities in APIs can be potentially toxic and can change the therapeutic properties of the final product significantly. The importance of impurity reference standards has become clear for the registration process, where exact identification and quantification of impurities is essential for documentation.

Our Impurity Characterized Standards portfolio comprises more than 5,000 compounds accompanied by a comprehensive CoA which can be found in 3 product categories that include a set of different analytical techniques for determining Identity and Purity.
Intended for non-compendial and methods validation applications.