Application note: Impurity analysis in pharmaceutical products with the advanced photodiode array detector SPD-M40

The accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing. This application note showcases the new photodiode array detector SPD-M40, which measures the concentration of impurities in pharmaceutical products.

Impurities in pharmaceuticals must be appropriately controlled to ensure product safety. The ICH guidelines on impurities in pharmaceutical substances¹ and impurities in drug products² have established specific thresholds for impurities. If the content of impurity in pharmaceuticals is more than 0.1 percent, it is necessary to identify its structure, perform the safety evaluation and report to the regulatory authorities. Therefore, the accurate determination of trace impurities is of great importance in both pharmaceutical drug development and drug manufacturing.