High-Sensitivity Analysis of Elemental Impurities
Elemental impurities in pharmaceuticals remain with the active pharmaceutical ingredients’ (APIs) raw materials or they are inadvertently introduced during the formulation and packaging processes. Their presence, even in small quantities, can influence the efficacy and safety of the product. Elemental impurity profiling is being emphasized by the various global regulatory pharmacopoeias and the International Conference on Harmonization (ICH). The United States Pharmacopoeia (USP) has revised elemental impurity limits and analysis techniques. These will be governed under USP <232>, <233>, <735>, and <2322>.
Inductively Coupled Plasma Mass Spectrometer
Accelerating Reliable Performance
The ICPMS-2030 provides excellent sensitivity, achieved by the optimized internal structure that includes a newly-developed collision cell. It also operates at a low running cost by minimizing the flow rate of argon gas necessary for analysis to the lowest level in the industry via the use of Shimadzu's proprietary mini torch and Eco mode.