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A Non-targeted Approach to Nitrosamine Screening down to PPB Levels
Ellutia, a leading provider of innovative analytical solutions, has recently launched the Automated Total Nitrosamine Analyser, a cutting-edge system that allows pharmaceutical companies and their suppliers to rapidly screen samples for total nitrosamine content down to ppb levels. The system is designed to supplement targeted nitrosamine testing, offering a faster and more comprehensive approach to identifying potential contaminants in pharmaceutical drugs.
The need for this technology stems from the discovery of NDMA in Sartans in 2018, which led to increased concerns over nitrosamines in pharmaceutical drugs. Nitrosamines are potent carcinogens that can be formed unintentionally during the chemical synthesis of active pharmaceutical ingredients (APIs). As time has progressed, the focus has shifted to other Nitrosamine drug substance-related impurities (NDSRIs), which are often more complex and difficult to detect.
Targeted nitrosamine testing, which involves testing for specific nitrosamines, has been the most common analysis method to date. However, this approach only detects what the tester is looking for and is limited to known nitrosamines for which standards are available. The Automated Total Nitrosamine Analyser overcomes these limitations by screening for total nitrosamine content, including unexpected nitrosamines for which standards may not exist.
The system offers a rapid and comprehensive approach to screening samples for nitrosamine content, allowing pharmaceutical companies to identify potential contaminants much more quicker. This enables them to focus their efforts using targeted analysis only on positive samples and avoid unexpected nitrosamine contamination from incoming ingredients.
Learn more about the Ellutia Automated Total Nitrosamine Analyser. More information online:
ilmt.co/PL/BKBb
60023pr@reply-direct.com The Affordable GC with Low Monthly Payments
Ellutia Chromatography Solutions now offer various monthly payment options for UK customers interested in purchasing a GC. Leasing or Hire Purchase options allow companies to avoid significant capital expenditure and may result in potential tax savings. The 200 series Gas Chromatograph’s already low entry price and a range of funding options make GC analysis more affordable to laboratories without sacrificing analytical performance. Systems can be configured for manual injection, or various autosampler options can be added.
The Ellutia 200 Series Gas Chromatograph is a compact, high-performance GC available at an affordable price, making gas chromatography accessible to every laboratory. Originally designed for educational purposes, the 200 Series GC is easy to operate and takes up minimal bench space, making it an ideal first GC for scientists seeking to start gas chromatography. The analytical performance of this instrument is comparable to that of larger, more expensive instruments from other manufacturers, allowing it to perform equally well in commercial labs and classrooms.
Learn more about Ellutia’s affordable GC solutions and monthly payment options. More information online:
ilmt.co/PL/w1vw and
ilmt.co/PL/w1vw
60037pr@reply-direct.com Automated Permeation Analysis Systems for EN 374
When handling dangerous chemicals, it is essential to wear protective clothing that has been tested to ensure it provides sufficient chemical protection. The level of protection is determined by testing the rate at which chemicals permeate through the material. For gloves to receive certification as ‘chemically protective’ by EN ISO 374-1, they must meet specific breakthrough times against several challenge chemicals.
Ellutia has developed an automated system for analysing permeation breakthrough rates. The system includes up to 18 permeation cells and optional automated challenge chemical introduction to increase sample throughput and automation. The cells hold the challenge chemical to one side of the sample material and periodically sample the headspace from the other side to plot the permeation breakthrough. The cells can be operated in series or parallel depending on the test requirements. The Ellutia 200 Series GC then analyses the headspace from the cells, and custom software automatically plots the results in real-time.
Learn about Ellutia’s automated permeation breakthrough analysis system. More information online:
ilmt.co/PL/JQed
60038pr@reply-direct.com
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