Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients

Novel fast dissolving freeze dried sublingual baicalin tablets for enhanced hepatoprotective effect: in-vitro characterization, cell viability, and in-vivo evaluation

Nagase Viita receives EcoVadis highest Platinum rating for sustainability

Preparation, Characterization, and Evaluation of a Novel Co-Processed Excipient as a Directly Compressible Vehicle in Antihypertensive Tablet Formulation

15. January 2017

Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients

Introduction

The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for elemental impurities in December 2014.1 Regulators are now implementing the requirements worldwide, with some start dates already in place as of June 2016.

ICH Q3D is the most comprehensive guideline for limits and risk assessment approaches for elemental impurities in final drug products to date; however, it does not specify limit for the major components of drug products. This brings excipients in particular under scrutiny, being they, unlike APIs, lack established daily doses.2 Given this, how can drug product manufacturers assess risk of elemental impurity to comply with ICH Q3D?

See more at

Elemental Impurities: Implications for Manufacturers of Drug Products, APIs & Excipients

By: Ulrich Reichert, PhD, Head of Pharma & Food Materials, Regulatory Management, Merck KGaA, Darmstadt, Germany
Drug Development & Delivery: Issue: January/February 2017, Posted Date: 1/13/2017

Elemental Impurities: Implications for M

Adobe Acrobat Document 1.8 MB

Download