Modernization of the Standards for Elemental Impurities - Pharmaceutical Technology

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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.


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