In April 2012, the Food and Drug Administration (FDA) will begin regulating the level of di(2-ethylhexyl)phthalate (DEHP) in bottled water. Manufacturers will be required to annually monitor their finished bottled water products and source water for DEHP in order to maintain compliance with current good manufacturing practice (cGMP) regulations.
Archive for the ‘Pharmaceuticals & Nutraceuticals’ Category
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.
By Gregory Salata, Ph.D., Kelso, WA
Many sampling programs include collection and analysis of an equipment blank to ensure there is no contribution of contaminants from the sampling equipment and associated process. To establish that sample collection procedures are contaminant free, an equipment blank is often collected. Equipment blanks are collected by passing water through the sample collection apparatus or utensil and collecting the water into the appropriate containers. To ensure that the water itself is contaminant free, the laboratory will supply the field crew with deionized (DI) water.
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.
For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.
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.