DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF ELEMENTAL IMPURITIES IN MICAFUNGIN FOR INJECTION

Abstract

Elemental impurities contained in a drug product create a risk for patients. Potential toxic elemental impurities are defined and classified in the Guideline for Elemental Impurities Q3D(R1). Among the finished product dosage forms, parenteral products could be critical for elemental impurities because elemental impurities go directly into systemic circulation. One of the most frequently used methods to determine elemental impurities is inductively coupled plasma-mass spectrometry (ICP-MS). In this study we aimed to develop and validate an ICP-MS method for the determination of 24 elemental impurities in micafungin powder 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 the 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.