USP <233> Elemental Impurities—Procedures

USP <233> outlines the analytical procedures for the evaluation of elemental impurities in pharmaceutical products, ensuring they meet the limits specified in USP <232>. This chapter describes two primary procedures for detecting elemental impurities: Procedure 1, which uses Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), and Procedure 2, which employs Inductively Coupled Plasma Mass Spectrometry (ICP-MS). The standard also provides criteria for the acceptability of alternative procedures, emphasizing the importance of system standardization and suitability evaluation using appropriate reference materials. The forms of sample preparation for the procedures are specified as well for different sample types, including closed vessel digestion.

USP <233> ensures the safety and efficacy of pharmaceutical products. Elemental impurities such as lead, mercury, arsenic, and cadmium can pose significant health risks if present in excessive amounts. By setting strict limits on these impurities, USP <233> helps protect patients from potential harm. The procedures described in this standard are designed to accurately quantify these impurities, ensuring that pharmaceutical products comply with regulatory standards.

The importance of USP <233> stems from its role in guiding pharmaceutical companies in the implementation of reliable and accurate methods for detecting elemental impurities. The use of ICP-OES and ICP-MS techniques is particularly advantageous due to their high sensitivity, precision, and ability to handle complex matrices. These methods allow for the direct analysis of samples with minimal preparation, making them practical and efficient choices for routine impurity monitoring.

Furthermore, USP <233> emphasizes the need for system standardization and suitability evaluation using certified reference materials. This ensures that the analytical procedures are consistently reliable and accurate, providing confidence in the results obtained. By adhering to the guidelines in USP <233>, pharmaceutical companies can maintain high standards of quality and safety, ultimately protecting patient health and ensuring regulatory compliance.

USP <233> is a critical standard for the pharmaceutical industry, providing detailed procedures for the evaluation of elemental impurities. The use of advanced analytical techniques such as ICP-OES and ICP-MS enhances the reliability and accuracy of impurity measurements, supporting compliance with regulatory requirements and maintaining high-quality standards in drug manufacturing.

With the PlasmaQuant MS series and the Plasma Quant 9100 series, Analytik Jena offers powerful, reliable and compliant solutions for ICP-MS and ICP-OES analyses to fulfill the requirements of the USP <233>. Moreover, the speedwave XPERT is an ideal instrument for closed vessel digestion as specified in the sample preparation section of the USP <233>.

For further information on the limits for elemental impurities in pharmaceutical products please check the article on USP <232>.

Our solutions for USP <233>

Sources

• Norm USP <233>: Elemental Impurities—Procedures