Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed, due to any side reactions. Impurity can be of three types: Impurities closely related to the product and coming from the chemical or from the biosynthetic route itself, Impurities formed due to spontaneous decomposition of the drug during the storage or on exposure to extreme conditions, or the precursors which may be present in the final product as impurities. Impurities present in excess of 0.1% should be identified and quantified by selective methods.
One important impurity for biologics is the degradation product of the drug. At Novabioassays we are specialized in various of analytical methods to isolate and characterize low percentage degradation products of the drug substance.