Eurofins SF Analytical Offers USP<611> Alcohol Content in Hand Sanitizer by GCFID
New Service Offering from Eurofins SF Analytical: USP<611> Alcohol Content
April 1, 2020: The COVID-19 pandemic has spiked consumer demand for alcohol-based hand sanitizer for personal disinfection as well as disinfectants for hard surfaces where the COVID-19 virus can be transmitted. This increased demand has pushed many new manufacturers of ethanol and isopropyl alcohol (IPA)-based hand sanitizing products into the market place.
Dave Riggs, business leader for Eurofins SF Analytical offers additional insight, “Hand sanitizers and related alcohol-based disinfecting agents have been in short supply due to the recent COVID-19 pandemic. New manufacturers ranging from personal care and cosmetics manufacturers to bulk alcohol producers want to assist by bridging supply with demand. Eurofins is honored to assist with testing of bulk ethanol, isopropanol, as well as the percent of ethanol, IPA, in hand sanitizer finished products.”
If sold commercially, manufacturers of these types of disinfecting products must perform testing to confirm alcohol content in order to comply with FDA and EPA guidance on product efficacy, sanitizing ability, and label claims.
For ethanol and IPA-based hand sanitizers to be effective as disinfecting agents, they must contain at least 60% ethanol or 70% IPA by volume. Manufacturers typically balance the formula with ingredients like aloe vera gel, fragrance, essential oil, and water. These formulations can pose problems to low-cost, unproven testing methodologies that are not compliant with US Pharmacopeia (USP) <611> guidance recognized by US FDA, EPA, and industry experts for alcohol-based disinfectant products.
Eurofins SF Analytical is pleased to offer two new test offerings to meet client demand for alcohol content in disinfecting products including hand sanitizer. The new offerings are as follows:
Alcohol Content (Ethanol, IPA) performed by GCFID according to USP<611>
- Standard turnaround time (TAT) of 10 calendar days
- Expedited turnaround is available for an upcharge
- At least 100 mL per sample are required
System Suitability for USP <611> Alcohol Determination: System suitability applies to each batch of samples received at one time (so only needed once per submission). This includes instrument daily suitability and calibration to ensure quality control is defensible against USP standards.
Eurofins SF Analytical can offer GMP validation to 21 CFR part 210/211 on a case-by-case if requested.
“As companies pivot to provide resourceful solutions, it is our hope to aid this process and bring their products to market more efficiently and seamlessly. Our goal is to provide analytical testing that meets the current guidelines of the US FDA for hand sanitizers under a robust quality system while performing these services with the urgency that our clients need at this time,” reflects Amber Skaretka, a technical project director at Eurofins SF Analytical.
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About Eurofins
Eurofins offers integrated solutions that span the entire food and supplement product life cycles. From concept to commercialization, Eurofins delivers integrated consulting, development, and testing services including product and process development; consumer research and sensory evaluation; nutritional and contaminant analysis; and food safety testing, consulting, and training. Our global network is composed of diverse teams of leading food scientists who provide a broad range of resources, experience, and expertise that enable our customers to bring innovative, sustainable, safe products to market, faster.
As one of the most innovative and quality-oriented international players in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world. With approximately 45,000 employees in more than 800 laboratories across 47 countries, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin, and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group’s highly qualified staff aims to provide its customers with high-quality services, accurate results on time and expert advice.
The shares of Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).
