An impurity profile collects the information of the identified and unidentified impurities present in a drug substance.
Organic impurities are of special concern in the development of synthetic drugs and due to the polar and nonvolatile nature of most compounds used as medicinal drugs, reversed-phase HPLC with detection of UV absorbance at a low wavelength is the most common technique for monitoring the drug substance and its impurities. This strategy maximizes the chance of detecting any unidentified impurity when using general wide chromatographic gradients.
Impurity profile becomes the starting step in the impurity studies developed in AMSbiopharma. We have HPLC and DAD instrumentation both from Waters and Agilent to effortlessly reproduce any chromatographic impurity profile.