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 Chris Leaf, Project Chemist, Kelso, WA

Imagine turning on a faucet to get a glass of water and discovering that perfluorooctane sulfonic acid, methyl tert-butyl ether, or chloromethane has flowed into your glass. These chemical compounds represent real threats to the public and are present in many public water supplies today.

In September of 2009, the EPA finalized its Contaminant Candidate List 3 (CCL3), comprised of 116 drinking water contaminants. These contaminants have already been discovered in public water systems or pose the risk of existing in public water supplies. Under the Safe Drinking Water Act (SDWA), the EPA is required to evaluate and determine whether to regulate at least five contaminants from the CCL every five years. The EPA decides if regulations will be required based on the following criteria¹:

• The contaminant may have an adverse effect on the health of persons.
• The contaminant is known to occur, or there is a great likelihood that the contaminant will occur in public water supplies with a frequency and at levels of public health concern.
• In the sole judgment of the EPA Administrator, regulation of the contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.

Read more about emerging contaminants and health risks…

Pharmaceutical manufacturers may face various challenges when attempting to meet the United States Pharmacopeia (USP) requirements for residual solvents (volatile organic chemicals).

Residual solvents in pharmaceuticals are trace level impurities of volatile organic compounds in final products or excipients. In general, residual solvents originate from manufacturing processes related to the preparation of drug products. They can also form during product packaging and storage.

Read more about USP 467…

Every day millions of gallons of treated and untreated wastewater are discharged into the waterways of the world. This wastewater may contain varying concentrations of pharmaceuticals and personal care products (PPCPs) including prescription and over the counter medications, nutraceuticals, illicit drugs, detergents, perfumes, insect repellent, sunscreens, and steroids, some of which have been identified in a recent article by The Associated Press¹.

Recent studies have shown that many of these PPCP compounds at low concentrations can have negative effects on the endocrine systems of aquatic organisms. These compounds are collectively known as Endocrine Disrupting Compounds (EDCs). Other concerns regarding PPCPs include contamination of drinking water, estrogenic effects on humans and wildlife, and development of antibiotic resistant bacteria.

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