Quantitative analysis was executed by the calibration curve method with standard sample aqueous solutions using two types of drug substance in powder form as the test materials. The instrument used was an EDX-7000 with the Pharmaceuticals Impurities Analysis Method Package (Shimadzu). This article describes an investigation to verify the appropriateness of energy dispersive X-ray fluorescence (ED-XRF) spectrometry as an alternative to the methods mentioned above with reference to the United States Pharmacopeia (USP). Application to existing drugs began in January 2018 in the United States, and in December 2017 in Europe.Īlthough the recommended analytical methods for elemental impurities are inductively coupled plasma-atomic emission spectrometry (ICP-AES) and ICP-mass spectrometry (ICP-MS), the use of appropriate alternative methods is also permitted when such methods exist. This requirement has applied to new drug products since June 2016 in the United States and Europe, and since April 2017 in Japan. The ICH Harmonised Guideline, Guideline for Elemental Impurities (ICH Q3D) of drug products, 1 requires control of the residual amounts of 24 elements whose toxicities are of concern. Shimadzu Europa GmbH, 47269 Duisburg, Germany
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