Analysis of Elemental Impurities in Pharmaceutical Products Following USP <232>/<233> on ICPMS-2030

Elemental impurities contained in pharmaceutical products are getting more and more attention due to their potential harm on patient health and the impact on drug shelf time and effectiveness. The United States Pharmacopeia (USP) has been continuously developing new guidelines in recent years to replace the over 100-year-old USP<231>. The Heavy Metal Limit Test procedure using colorimetric test method in the USP<231> is no longer adequate for quantitation of elements at toxicologically relevant levels. The new USP guidelines for elemental impurities has been implemented since 1 January 2018. After harmonized to ICH Q3D, USP<232> specifies the impurities limits for 24 elements based on their toxicity. USP<233> recommends two modern measuring techniques (i.e. ICP-OES and ICP-MS) and the measuring and validation procedures. ICP-MS is indisputably considered as the best technique for determination of the 24 elements at trace levels in pharmaceutical products because of its superior sensitivity and simultaneous analysis capability of multi-elements. This application news describes the ICPMS procedure and results for analysis of 23 elemental impurities in three pharmaceutical products following USP<232>/ <233> criteria on ICPMS-2030.

Content Type:
Document Number:
Product Type:
Elemental Analysis, Inductively Coupled Plasma Emission Spectroscopy
USP <232>/<233>, ICPMS, elemental impurity, metal contamination, PDE, Environment, Pharmaceutical, Life Science, ICPMS-2030
File Name:
File Size:

View Article

For Research Use Only. Not for use in diagnostic procedures.

This page may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country.

Top of This Page