Application of R3/R5 Microwave Digestion Systems in the Elemental Analysis of Active Pharmaceutical Ingredients (APIs)

Abstract

In pharmaceutical synthesis, heavy metal catalysts are commonly used, and their residues often remain in the final product. These heavy metals—primarily from catalyst residues—not only affect drug efficacy but also pose serious health risks to patients. As a result, pharmacopoeias in various countries impose strict limits on heavy metal content in pharmaceutical substances.

This application demonstrates the use of the R3/R5 microwave digestion systems to prepare samples of carbamazepine, an active pharmaceutical ingredient (API), for trace metal analysis. The method ensures complete digestion with minimal loss of volatile elements, making it ideal for regulated pharmaceutical testing.