Navitas Life Sciences

Total and Transferrin Bound Iron Assay for Iron Sucrose Formulations – Application in Regulated Bioanalysis

Iron deficiency is the most common nutritional disorder in the world, affecting approximately 25% of the world’s population, and the most common cause of anemia. Iron deficiency may be treated with intravenous iron therapy. In response, we have researched the complexities of iron preparations and have established robust methodologies for evaluating Iron-Carbohydrate preparations. Our Iron sucrose bioanalysis has helped our clients to bring their iron preparation products to market faster.

We have conducted 1500+ Bioequivalence studies, with over 100+ marketing authorizations, and have developed some 450+ bioanalytical methods. We follow Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) and are ISO 9001-2015 and ISO 27001-2013 certified for our Quality Management System. Our clinical testing laboratories are also certified by both The National Accreditation Board for Testing and Calibration Laboratories (NABL) and the College of American Pathologists (CAP).

Please complete the form to download our Iron Sucrose Study brochure and learn how you can leverage our experience and reliable bioanalytical methods expertise that can precisely differentiate and quantify transferrin bound form, in addition to total iron, to support the evaluation of your bioequivalence and/or safety studies.

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