New Limits and Procedures for Elemental Impurities in Pharmaceuticals and Dietary Supplements

By Jeff Grindstaff and Colleen Schroeder

Changes to heavy metals test procedures for the analysis of pharmaceuticals and dietary supplements are under review with new standards set to be in place by mid-2013.⁴ The intention of the review is to update current analytical testing historically performed using United States Pharmacopeia (USP) <231>. The revisions (USP<232>, USP<233>, and USP<2232>) are designed to set safer limits for public exposure and to reduce the environmental impact of dated methods. Many in the pharmaceutical industry have concerns about the new instrumentation, more stringent requirements, and the associated costs. Nonetheless, the revisions should have a beneficial impact on the industry by significantly improving specificity and analyte recoveries, as well as by yielding overall time savings resulting in safer, higher quality products.

Read more about Heavy Metals…

By Elisabeth Lutanie, Ph.D.

Cadmium is a transitional metal that can have harmful cumulative effects on the human body. This article explains what cadmium is, where it comes from, how people get exposed to it, and how laboratories can test for it.

What is Cadmium?

Cadmium (Cd, atomic number 48) is a silver- or bluish-white metal in the group 12 of the periodic table. It is usually found with an oxidation state of +2 and combined with other elements such as oxygen (cadmium oxide), chlorine (cadmium chloride), or sulfur (cadmium sulfate, cadmium sulfide). It is also a cumulative poison associated with an array of syndromes such as renal dysfunction, reproductive toxicity, and bone defects. It is classified as a human carcinogen (Group 1) by the International Agency for Research on Cancer [1], and as a probable human carcinogen (Group B1) by the Environmental Protection Agency (EPA).  

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by Alyson Fortune, Air Quality Scientist; Michael Tuday, Director of R&D; Nicole Pannone, Air Service Specialist

For the past four years, the U.S. Consumer Product Safety Commission (CPSC) has been receiving complaints from homeowners regarding corrosion and odors in their homes linked to imported drywall. The problem drywall, which was installed in homes between 2004 and 2007 and is commonly referred to as “Chinese drywall,” has resulted in more than 2,500 complaints to the CPSC. The complaints originated from homeowners primarily in the southeastern part of the United States, but have since been reported throughout the country.

Homeowners have linked their Chinese drywall to corrosion in their air conditioner coils, corrosion in copper wiring, and emission of foul odors. The odors have been described as smelling like rotten eggs, burnt matches, and other sulfurous smells.

Columbia Analytical has been studying this issue and testing both foreign and domestic drywall samples since February 2008. Laboratory tests have been developed to aid in the identification of defective drywall products. These tests may be used to verify visual home inspections and determine if corrosion effects are from drywall and not from other household items, such as carpets, cleaners, paints, or personal care products.

This article presents a chronology of how Columbia Analytical established their test methods for determining problem drywall and how each of the issues that arose was resolved with a laboratory solution.

See Chinese drywall lab tests and results…

1,4-Dioxane (dioxane) is a chemical of concern for its potential health effects as a carcinogen and irritant. It is commonly found in personal care products such as detergents, shampoos, body lotions, and cosmetics, and is widely used as an industrial solvent and stabilizer in manufacturing processes (e.g., electronics, metal finishing, fabric cleaning, pharmaceuticals, herbicides, pesticides, antifreeze, paper, etc.). Currently, there are no established limits on the amount of dioxane in personal care products nor is it specifically regulated in manufacturing wastewater streams that may impact the surrounding environment. Manufacturers of personal care products should conduct laboratory analysis to determine the levels of dioxane in their products, and manufacturers using dioxane in their processes should analyze their waste streams for possible dioxane content.

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Ultra-trace speciation of arsenic and other metals is performed using a variety of techniques tailored to the specific combination of species, matrix, and detection limits required. Currently, two analytical systems are applied: Ion Chromatography-Inductively Coupled Mass Spectrometry (IC-ICP-MS) and Hydride Generation-Cryogenic Gas Chromatography-Flame Atomic Absorption Spectrometry (HG-CGC-AAS). Each of these techniques has particular strengths that can be exploited depending upon the scientific question being asked. These techniques are combined with specific extraction techniques in order to maximize speciation integrity and data quality.

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What is RoHS/WEEE?

In 2003 legislation was introduced in the European Union (EU) to promote the collection, treatment, recycling, and recovery of waste from electrical and electronic equipment. This legislation is known as the Waste Electrical and Electronic Equipment (WEEE) act and is formally dictated by directive 2002/96/EC of the European Parliament. A complimentary directive, the Restriction of Hazardous Substances (RoHS), was also introduced in 2003 given by 2002/95/EC of the European Parliament. Beginning July 1, 2006, RoHS legislation restricts the amounts of lead, cadmium, mercury, chromium (VI), Polybrominated Diphenylethers (PBDEs), and Polybrominated Biphenyls (PBBs) in electronic and electrical equipment. These chemicals are known to present a risk to human health and the environment. Thus, restrictions are in place that limit the concentration of these constituents in electrical and electronic products and/or components.

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Introduction: Historical mining practices in the Coeur d’Alene River Basin (Idaho) have resulted in heavy metal contamination of soil, sediment, surface water, and groundwater. Canyon Creek, located in the upper basin, has elevated levels of dissolved zinc (average concentration ~ 3,000 μg/L), dissolved cadmium (average concentration ~ 22 μg/ L), and total lead (average concentration ~ 174 μg/L). Heavy metal loading near the mouth of Canyon Creek is influenced by surface water/groundwater interactions. Dissolved zinc concentrations in the groundwater have been detected in the 100,000 μg/L range while dissolved cadmium and lead have been detected in the hundreds to thousands μg/L ranges, respectively.

EPA’s consultant, URS Corporation (URS), developed a multi-phase treatability study to obtain quantitative information on a treatment process to effectively remove metals from the water of Canyon Creek. The treatment process incorporated different combinations of pH adjustment, chemical coagulation and coprecipitation, polymer flocculent additions, and additions of ballasted micro-sand to improve sludge settling. The results of the study will be used to help evaluate potential treatment technologies for surface water and/or groundwater at Canyon Creek. These data will also be used to help develop the pilotscale treatability study for Phase II of the study.

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