Development and validation of analytical method for determination of elemental impurities in micafungin for injection

Abstract

Elemental impurities contained in drug product create a risk for patients and potential toxic elemental impurities defined and classified in Guideline for Elemental Impurities Q3D(R1). Among the finished product dosage forms, parenteral products could be critical for elemental impurities because elemental impurities are given directly to systemic circulation. For determination of elemental impurities, one of the most frequently used methods is inductively coupled plasma–mass spectrometry (ICP–MS). In this study we aimed to develop and validate an ICP-MS method for determination of 24 elemental impurities in micafungin powder for concentrate for solution for infusion manufactured in our own facility. Results showed that correlation coefficients of calibration curves were found higher than 0.99 for all elements in determined ranges and all validation parameters were achieved successfully. With this method, all 24 elemental impurities can be tracked throughout the shelf life of the product.

Keywords

• icp-ms
• validation
• elemental impurities
• micafungin
• injectables