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Ellutia presents failsafe total nitrosamine testing in pharmaceuticals at Pittcon 2020

Ellutia

Ellutia is presenting its nitrosamine testing solution for pharmaceuticals using its 800 Series Thermal Energy Analyser with Chemical Stripping System

2 Mar 2020
Cameron Smith-Craig
Cameron Smith-Craig
Pharma and Applied Sciences Editor

Industry news

Nitrosamines are back in the news following the mass recall of a popular US heartburn medication, prompting the US Food and Drug Administration to call in various drugs known as ARBs for testing, and suppliers like Novatis and Sanofi to cease distribution.

In Europe, the European Medicines Agency (EMA) has requested that Marketing Authorization Holders of all Finished Pharmaceutical Products (FPPs) conduct a risk assessment to determine the potential for nitrosamine content. This is particularly relevant for the nitrosamines NDMA and NDEA that belong to the WHO ‘cohort of concern,’ classified as ‘probable human carcinogens.’

The 800 Series TEA interfaced with Ellutia’s proprietary chemical stripping system is a unique instrument on the market that offers total nitrosamine analysis of pharmaceutical products. The system allows rapid and accurate quantification of the total nitrosamine content of a sample.

Measuring apparent total nitrosamine content (ATNC) provides a benchmark of the nitrosamine volume in a product. Rather than embark on a lengthy analytical process to deliver detailed and speciated results in the first instance, the ATNC method screens only for the total nitrosamine content (this includes both volatile and non-volatile nitrosamines) and returns an analysis with a single clear peak. This peak either falls within or outside the interim allowable daily intake set by the World Health Organization (WHO) for specific species of nitrosamines. If the peak of the total sample falls within the daily intake allowance, then no single nitrosamine can possibly be above the value and the nitrosamine content is reported as safe.

In contrast, any sample found to contain an ATNC outside the safe level can be red flagged and sent for further analysis by a TEA interfaced with a GC or HPLC to individually identify the species and quantify the presence of nitrosamines such as NDMA.

Ellutia’s 800 series TEA and chemical stripping system offers rapid time to results for ATNC, with a typical single-peak analysis taking just between one and ten minutes.

Andrew James, marketing director at Ellutia, said: “The risk assessment requirement from the European medicines agency means that pharmaceutical manufacturers need to take a serious look at potential nitrosamine contamination in their product lines. By adopting the ATNC quantification method in the first instance, any sample that results in a safe analysis can be passed immediately. Any sample found to contain levels outside the safe value can be sent for further analysis with the TEA system.”

Ellutia will also hold live demonstrations of its 500 Series GC (gas chromatograph) on stand at Pittcon, offering conventional, fast and ultrafast chromatography in a single system, freeing up valuable space in the lab.

The TEA has become an industry go-to for nitrosamine testing and has set a high standard in this application in the food industry. Coupled with Ellutia’s Chemical Stripping System, the instrument is now seeing success in pharmaceutical testing.

Ellutia Chromatography Solutions Ltd, stand 2326, Pittcon 2020, March 1-5, Chicago

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Gas ChromatographyGas chromatography (GC) is an analytical technique used to separate and quantitate mixtures of small and volatile compounds. Gas chromatographs or GC systems include components such as GC columns, detectors, pumps and autosamplers. Choose from packed or capillary GC columns, flame ionization (FID), photoionization (PID) electron capture detectors and selective or non-selective detectors. Find the best gas chromatographs in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Drug TestingIt is essential to test the efficacy and toxicity of drugs at every stage of their development to ensure that a pharmaceutical product is fit for purpose and safe for use before reaching the stage of mass production and distribution.PittconPittcon is one of the largest conferences and exhibitions dedicated to laboratory science. It brings together professionals and innovators in analytical chemistry, physics, and biology, offering a platform to explore the latest scientific tools and technologies. From cutting-edge laboratory instruments to emerging research trends, Pittcon is a must-attend event for professionals in research and development. ChromatographyChromatography is a powerful technique used to separate and analyze components of mixtures based on their chemical properties. It is widely used in fields like biochemistry, pharmaceuticals, and environmental analysis. By exploiting differences in the interaction of substances with a stationary phase and a mobile phase, chromatography enables precise purification and quantification of compounds. Whether you're working with complex biological samples or industrial chemicals, chromatography is essential for obtaining high-quality results. Browse our peer-reviewed product directory to find the best chromatography systems, compare products, read customer reviews, and get pricing directly from manufacturers.WHOPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.

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