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Analytical method development and optimization

Development and optimization phases during the drug life cycle are crucial. We’re fully aware of that fact, and we work in an efficient and flexible manner, using the best industry practices, in order to support our clients at this important stage of the process. Our team consist of industry experts with a thorough understanding of the process and long-standing expertise in the field, complemented with appreciation of the latest trends in analytical and bioanalytical chemistry.

At this stage we develop and test new analytical and bioanalytical methods. When do we develop a new method? We usually do this in several cases: when the existing method described in the guidelines is obsolete or does not meet the clients’ requirements; for new medicinal product when there is no efficient method for purity determination or assay; when the final product is a mixture of different active ingredients.

For method development we use either HPLC or UHPLC. Our analytical department is equipped with liquid chromatographs Agilent 1260 Infinity II and 1290 Infinity II (Agilent Technologies), Ultimate 3000 RS UHPLC and Ultimate 3000 SD HPLC (ThermoFisher Scientific) with DAD-UV, PDA, FLD, CAD, ELSD detectors.

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