Pharmaceutical Research

, Volume 27, Issue 5, pp 750–755 | Cite as

Metal Impurities in Food and Drugs

  • Darrell R. Abernethy
  • Anthony J. DeStefano
  • Todd L. Cecil
  • Kahkashan Zaidi
  • Roger L. Williams
  • USP Metal Impurities Advisory Panel
Commentary

Abstract

The major metals of potential health concern found in food, drugs (medicines), and dietary supplements are lead, cadmium, mercury, and arsenic. Other metals, such as chromium, copper, manganese, molybdenum, vanadium, nickel, osmium, rhodium, ruthenium, iridium, palladium, and platinum, may be used or introduced during manufacturing and may be controlled in the final article as impurities. Screening for metals in medicines and dietary supplements rarely indicates the presence of toxic metal impurities at levels of concern. The setting of heavy metal limits is appropriate for medicines and is appropriate for supplements when heavy metals are likely or certain to contaminate a given product. Setting reasonable health-based limits for some of these metals is challenging because of their ubiquity in the environment, limitations of current analytical procedures, and other factors. Taken together, compendial tests for metals in food and drugs present an array of issues that challenge compendial scientists.

KEY WORDS

analysis impurities limits metals standards US Pharmacopeia 

Abbreviations

ATSDR

Agency for Toxic Substances and Disease Registry

CDC

Centers for Disease Control and Prevention

cGMP

Current Good Manufacturing Practices

EPA

Environmental Protection Agency

FDA

Food and Drug Administration

GFAAS

Graphite Furnace Atomic Absorption Spectroscopy

IARC

International Agency for Research on Cancer

ICP-OES

Inductively Coupled Plasma–Optical Emission Spectroscopy

ICP-MS

Inductively Coupled Plasma–Mass Spectroscopy

IPCS

International Program on Chemical Safety

IRIS

Integrated Risk Information System

JECFA

Joint Expert Committee on Food Additives

LOAEL

Lowest Observed Adverse Effect Level

MRL

Minimal Risk Level

NA

Not Applicable

ND

Not Determined

NOAEL

No Observed Adverse Effect Level

OEHHA

Office of Environmental Health Hazard Assessment

PDE

Permissible Daily Exposure

RfD

Reference Dose

USP

US Pharmacopeial Convention

WHO

World Health Organization

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Darrell R. Abernethy
    • 1
  • Anthony J. DeStefano
    • 1
  • Todd L. Cecil
    • 1
  • Kahkashan Zaidi
    • 1
  • Roger L. Williams
    • 2
  • USP Metal Impurities Advisory Panel
  1. 1.Documentary Standards DivisionUS PharmacopeiaRockvilleUSA
  2. 2.Chief Executive OfficerUS PharmacopeiaRockvilleUSA

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