
Analytik Jena AG
Determination of Elemental Impurities in Pharmaceuticals
Pages
13
Time to read
26 mins
Publication
Language
English

Pages
13
Time to read
26 mins
Publication
Language
English
This case study explores the use of PlasmaQuant 9100 Elite high-resolution ICP-OES technology for determining trace elemental impurities in pharmaceutical products. It discusses compliance with USP chapters <232> and <233>, and ICH Q3D guidelines, highlighting the system's sensitivity, robustness, and ability to analyze diverse sample types efficiently. The document emphasizes the importance of accurate quantification for pharmaceutical safety and regulatory compliance.