Modernization of the Standards for Elemental Impurities - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Modernization of the Standards for Elemental Impurities
Recent activity in standards-setting organizations has raised interest in the impact of testing for impurities that may enter the product before it is mined or harvested or even due to intentional use of some reagents.

Pharmaceutical Technology
Volume 37, Issue 2


Modernization of the heavy-metals standard has been a long time in development and involves experts from all over the world. The improvements include being able to identify the contaminant and being able to measure it at levels where toxic impacts occur. The new term for this standard has changed from "Heavy Metals" to "Elemental Impurities" to reflect these improvements.

Harmonization efforts are proceeding through normal channels at ICH and the parties are agreed to standardize limit criteria whenever the same metals are involved. The normal process of harmonizing existing regional standards is being used.

Jon E. Clark is the Associate Director for Program Policy in the FDA Office of Pharmaceutical Science. He is a founding member of the ICH Expert Working Group on Elemental Impurities (Q3D) and has been a member of multiple ICH working groups,
. John S. Punzi, PhD, is Director, Quality Assurance & Technical Affairs at CHPA.


1. D. Abernathey et al., Pharm. Research, 27 (5) 750-755 (May 2010).

2. K. Blake, Pharmacopeial Forum 21 (6) 1632-1637 (Nov.-Dec. 1995).

3. USP, USP-NF 1S to USP 28 (2005).

4. Wang et al., Pharmacopeial Forum 29 (4) 1328-1336 (July-August 2003).

5. N. Lewen et al., J. Pharm and Biomed Analysis 35 739-752 (2004).

6. EMA, Guideline On The Specification Limits For Residues Of Metal Catalysts Or Metal Reagents (London, Feb. 21 2008),, accessed Jan. 16, 2013.

7. USP, Pharmacopeial Forum 36 (1).

8. ICH, Quality Guidelines,, accessed Jan. 16, 2013.

9. J.F. Kauffman, Reg. Toxicol. and Pharmacol. 48 (2) 28–134 (2007).

10. FDA, Drug Shortages,, accessed Jan. 9, 2013.

11. IPEC, ICH Q3D Information Exchange Request,, accessed Jan. 9, 2013.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here