Common Pitfalls in Extractables & Leachables Testing

Jun 20 2019

Extractable and Leachable Regulations & Requirements Extractables and leachable studies are required for pharmaceutical product submissions in order to ensure that plastic and rubber chemicals do not transfer into drug products at levels that cause public health concerns.  These studies are customized and although there exist guidances from both the United States Pharmacopeia (USP) as…

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Avomeen Hires New Head of Elemental Analysis

Jun 17 2019

John Ferencz brings 12 years of chemistry experience to Avomeen to help grow its elemental analysis testing capabilities Avomeen Analytical Services recently announced John Ferencz as the new leader of its Elemental Analysis division. In this role, he will be responsible for overseeing a growing lab unit that specializes in analysis of heavy metals and…

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Choosing the Right Lab for PMTA Compliance

Jun 17 2019

The e-liquid and vaping industry is evolving and maturing, and you’re going to need a full service lab and partner to help you navigate the regulatory landscape to obtain Premarket Tobacco Application (PMTA) authorization for ENDS, per the June 2019 guidance. You’ll need to weigh your options and choose the right partner – one that…

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What You Need to Know About the FDA’s New PMTA Guidance

Jun 13 2019

FDA ENDS Regulations & Authorization To create or modify a new tobacco product, including e-juice/e-cigarette brands and vape juice ingredients for Electronic Nicotine Delivery Systems (ENDS), you need to comply with newly released FDA tobacco regulations and undertake Premarket Tobacco Product Application (PMTA) testing. Before marketing the product, manufacturers must first obtain authorization from the…

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USP 232/233 Elemental Impurities FAQs: Part 1

Jun 11 2019

FDA Requires Compliance to USP 232/233 The United States Pharmacopeia (USP) <232> and <233> chapters specify the limits and procedures for the screening and quantification of potentially toxic metal impurities. Elemental impurities don’t provide any therapeutic benefits, and their levels in a drug product should be controlled within the acceptable limits set forth in FDA…

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Chemistry is FUNdamental Educational Program

Jun 6 2019

We recently hosted 35 students and teachers from Ann Arbor Learning Community as part of Avomeen’s Chemistry is FUNdamental program. The program fosters interest in STEM fields from a young age by performing exciting demonstrations that feature 4 different concepts that are important in the field of chemistry. Chromatography Think chromatography is too advanced for…

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The Long and Short of USP Guidelines for E&L Testing

Jun 4 2019

Sources of Impurities in Pharmaceutical Products In the development of a drug product, careful consideration needs to be given to impurities that may originate from manufacturing equipment, process components, and packaging materials. The majority of such impurities are common chemical additives used to improve the physicochemical properties of a wide range of plastic materials. Suppliers…

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Canoe Believe It! Community Service Event

May 30 2019

We combined fun with environmental stewardship during our “Canoe Believe It!” Event Saturday, May 18, 2019 on the Huron River in Ann Arbor, Michigan. Members of the Avomeen team and some of their adventurous family members canoed along the Huron River from Gallup Park Canoe Liveries. While canoeing and enjoying the Huron River is an…

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Our Top 5 Instruments

May 28 2019

As an analytical testing laboratory, we could not survive without some of our bread-and-butter instruments, including gas chromatography (GC) and high performance liquid chromatography (HPLC). However, other instrumentation has quickly become pivotal to the growth of Avomeen. Keep reading to find out which instruments made our “Top 5” list. 5) Dissolution Apparatus The purpose of…

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Giving is our Jam Food & Fund Drive

May 24 2019

We have big brains, but did you know we have big hearts too? Our team is committed to giving back and supporting the community in which we live and work. To kick-off Avomeen’s community involvement initiatives in 2019, a food and fund drive, aptly named “Giving is our Jam”, was held from April 15-May 3…

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