TY - JOUR
T1 - Metal impurities in food and drugs
AU - Abernethy, Darrell R.
AU - DeStefano, Anthony J.
AU - Cecil, Todd L.
AU - Zaidi, Kahkashan
AU - Williams, Roger L.
N1 - Funding Information:
1Documentary Standards Division, US Pharmacopeia, Rockville, Maryland 20852-1790, USA. 2Chief Executive Officer, US Pharmacopeia, Rockville, Maryland 20852-1790, USA. 3To whom correspondence should be addressed. (e-mail: ajd@usp.org) 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.
PY - 2010/5
Y1 - 2010/5
N2 - 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.
AB - 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.
KW - Analysis
KW - Impurities
KW - Limits
KW - Metals
KW - Standards
KW - Us pharmacopeia
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U2 - 10.1007/s11095-010-0080-3
DO - 10.1007/s11095-010-0080-3
M3 - Comment/debate
C2 - 20217462
AN - SCOPUS:77953286307
SN - 0724-8741
VL - 27
SP - 750
EP - 755
JO - Pharmaceutical Research
JF - Pharmaceutical Research
IS - 5
ER -