The Analytical department is a division of Scientific Affairs and is responsible for developing protocols and procedures that are used for the testing of the ingredients that go into newly developed pharmaceutical products. The group is also responsible for the development and validation of analytical test procedures that are used to assure overall product quality and safety. Analytical Development scientists utilize scientific principles to establish stability profiles of our products and make shelf-life projections for all new products. The group provides Regulatory Affairs with a major portion of the chemistry, manufacturing and controls section of a New Drug Application.
In order to perform highly specialized research and development functions, the Analytical Development laboratory at Mylan Specialty has been equipped with state-of-the-art analytical instrumentation such as LC/MS, FTIR, UV/VIS and atomic emission/absorption spectrometers, high performance liquid chromatographs with photodiode array, electrochemical, evaporative light scattering, fluorescence and other specialized detectors, gas chromatographs, particle size and droplet size analyzers including cascade impactors, digital spray pattern and geometry analyzers.