Analysis of Elemental Impurities in Oral Drug Products Using ICPMS-2040/2050 ―ICH Q3D―

User Benefits

- Robust quantitative analysis of control thresholds even when Option 1 (ICH Q3D) is used to convert PDEs to concentration limits - Easily meets acceptance criteria for accuracy and precision for the analytical procedure used to quantify elemental impurities - Preset methods eliminate the labor needed to establish analytical conditions and allow anyone to perform analysis with ease

Introduction

ICH Q3D (R2) Guideline for Elemental Impurities establishes permitted daily exposure (PDE) levels for 24 elements of toxicological concern. The guideline requires that levels of these elements be controlled by appropriate analytical methods. In response to this guideline, section “2.66 Elemental Impurities” was included in the Japanese Pharmacopoeia (JP), sections “<232> Elemental Impurities―Limits” and “<233> Elemental Impurities―Procedures” were included in the United States Pharmacopeia (USP), sections “5.20 Elemental Impurities” and “2.4.20 Determination of elemental impurities” were included in the European Pharmacopoeia (EP), and inductively coupled plasma mass spectrometry (ICP-MS) was added as an analytical method. This Application News describes using the ICPMS-2050 to analyze commercially available oral drug products (a gastrointestinal drug). Assuming that elemental impurities are measured at concentrations lower than 30 % of the PDE (control threshold), accuracy, precision, and quantitative limits were confirmed in an example analysis performed according to the quantitative procedures described in the JP, USP, and EP.

8 de agosto de 2023 GMT