Impurity reference standards (including a broad range of degradation products)

Impurities are always present in a therapeutic substance and can significantly alter a drug’s effects on the patient, potentially putting their health at risk. Legislators and official bodies, therefore, set limit and threshold values as well as guidelines requiring the detection, identification, quantification, and qualification of impurities. The Mikromol portfolio of over 4,000 impurity reference standards is of the highest quality and designed to aid your detection of degradation products in APIs and excipients, as well as process impurities, with a renewed focus on genotoxic impurities. The standards may be used for the quantification of impurities, as well as for identity and limit tests, according to ICH guides Q2, Q3A,and Q3B.

Each Mikromol impurity standard comes complete with information on two assay methods unless not technically feasible – in which case we measure additional parameters internally to ensure quality and reliability to give you greater analytical certainty and confidence that your results are accurate.