Various Approaches for Trace Analysis in Active Pharmaceutical Ingredients

Michael Tikhonov, Analytical R&D, Teva- TAPI, Petach Tikva, Israel

Development of trace analysis methods is a substantial challenge in analytical chemistry of Active Pharmaceutical Ingredient (API) , and a crucial step towards delivery of safe drug substances .

Applying different approaches on various analytical techniques and sample preparation enables the development of highly sensitive and accurate methods. Such tasks are performed daily in TAPI Analytical R&D. The development is performed with special attention to achieve a balance between the technical complexity and the requires simplicity needed for implementation in Quality control Labs.

In such cases matrix effects (highly concentrated sample solutions ) and the demand for increased sensitivity , elevate the importance of making the right combination between extraction techniques and the suitable chromatographic tools.

Traces analysis provides the greatest challenges in analytical chemistry and the most innovative solutions.