Analysis by ICP Atomic Emission Spectrometry in Accordance with the ICH Q3D Guideline for Elemental Impurities Using ICPE-9820

Introduction

Analysis of elemental impurities is one of the safety assessments required in the field of pharmaceuticals. In Japan, residual metal catalysts are classified as inorganic impurities according to the guidelines for Impurities in New Drug Substances (No. 1216001, issued by the Evaluation and Licensing Division, the Pharmaceutical and Food Safety Bureau, the Japanese Ministry of Health, Labour and Welfare), and are to be detected appropriately according to the method specified in the Japanese Pharmacopoeia, and evaluated at the stage of drug development. At the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH, various guidelines were established and harmonized between Japan, Europe, and the US, including guidelines for elemental impurities in pharmaceuticals, referred to as the ICH Q3D, Guideline for Elemental Impurities. For the analysis of elemental impurities, the methods specified for use as general analytical methods in the First Supplement of the Sixteenth Edition of the Japanese Pharmacopoeia include inductively coupled plasma atomic emission spectrometry (ICP-AES), inductively coupled plasma mass spectrometry (ICP- MS), and atomic absorption spectrometry. Of these, ICP-AES is the most convenient, offering quick and easy multi-element analysis, and low running costs. Here, we conducted analysis of 24 elements according to the ICH Q3D guidelines using the Shimadzu ICPE- 9820 multi-type ICP atomic emission spectrometer. The ICPE-9820 offers simultaneous all element analysis with high sensitivity and high precision, while delivering high throughput. Low running costs are achieved by a unique combination of the reduced-flow mini-torch and vacuum optics, thereby reducing the overall consumption of argon.

June 2, 2015 GMT