Quantification of impurities
We are experts in the quantification of substances in complex matrices. Due to our many years of experience in quantitative bioanalytics, we possess the expertise required for the development, validation and implementation of LC-MS-based quantitative methods and limit tests, in particular for low concentrated impurities. Our experienced employees draw on this knowledge for corresponding studies under GMP.
Our ability to establish valid methods for even the most challenging analytes, or analytes with very low detection and determination limits, underlines our excellence in the field.
We employ generic method approaches for many typical process impurities, that are tested during the production of biopharmaceuticals, which we can readily adapt to your product.