Addressing the Challenges of Targeted Nitrosamine Testing in the Pharmaceutical Industry.

The pharmaceutical industry has reported serious difficulties pertaining to targeted nitrosamine testing. These hurdles chiefly stem from the demanding and time-consuming nature of chromatographic techniques, compounded by substantial financial burdens associated with procuring and maintaining the requisite equipment, alongside trained personnel. Additionally, the intricate extraction processes often result in analytical losses.
 
Nitrosamines can present themselves in diverse forms. As stipulated by EU regulation 726/2004, there are 27 distinct known nitrosamines, each with a unique permissible daily intake level that spans from 8ng/day to 78,000ng/day.  There is also the potential for previously unknown nitrosamines to be formed from the APIs themselves. This broad range adds complexity to targeted screening, making it both laborious and exorbitantly costly to detect each type of nitrosamine individually.
 
Several risks are associated with nitrosamine contamination in pharmaceutical manufacturing. These include potential occurrences in raw materials, water supply, and even packaging. The threat posed by nitrosamines is emphasised by the fact that concentrations, even at minimal levels, can exceed daily limits. 
 
In response, Ellutia has developed the automated total nitrosamine analyser.  Allowing for a non-targeted approach to nitrosamine testing. The system utilises the 800 series TEA (Thermal Energy Analyser), a globally utilised detector for nitrosamine analysis. This allows users to see both volatile and non-volatile nitrosamine content down to 1 ppb in a single result. Because the detection method targets the nitrosamine functional group rather than specific compounds, it means that standards for all nitrosamines present are not required to detect them.
 
This allows users to quickly screen samples for nitrosamine content and then only pass positive samples on for further speciated analysis. 
 
Given the expanding array of nitrosamine types, non-targeted testing offers a pragmatic approach for screening both raw materials and finished products. Ellutia's innovative solutions are designed to equip the pharmaceutical industry with reliable, cost-effective strategies for nitrosamine testing.
 
To explore if a non-targeted approach to nitrosamine testing solutions and take the next step towards ensuring the safety and quality of your products. Visit our website to learn more about the automated total nitrosamine analyser.  
 

Ellutia understands that every company’s nitrosamine testing requirement is unique and the importance of personalised guidance, tailored to your specific nitrosamine testing needs. That's why they invite you to arrange an initial call with one of their dedicated specialists. Together, your requirements can be discussed and the best strategies for your organisation's success will be found. To arrange an initial discussion, please visit Ellutia's website.

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