Development of analytical methods, impurity studies, degradation studies, and more. Thanks to our analytical expertise and state-of-the-art equipment, we support our clients in the drug development and registration phases by following the latest trends in analytical chemistry.
Product-specific analytical methods are developed using international guidelines (Turkish Pharmacopoeia, European Pharmacopoeia, American Pharmacopoeia, and British Pharmacopoeia, etc.) and validated in terms of accuracy, precision, selectivity, recovery, and robustness parameters.
Studies are conducted in accordance with ICH stability guidelines to determine the shelf life and storage conditions of the products.
Analyses are performed to identify potential organic impurities and degradation products that may be present in the products.
Raw materials and finished products are analyzed for compliance with defined specifications.
We provide support for analytical strategy, method selection, and technical reporting for R&D and licensing processes.