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Analytical Systems for Nitrosamine Impurities
Nitrosamine specific detection for the Pharmaceutical industry
NITROSAMINE ANALYSIS IS HARD
Complex samples, interfering compounds, low detection limits, false positives, lack of analytical standards can all make nitrosamine analysis a real headache. But it doesn't need to be like that!
Total Nitrosamine Analysis
Apparent total nitrosamine content (ATNC) gives a single result that confirms the presence of nitrosamine content regardless of nitrosamine molecule present. This allows rapid screening of samples to confirm the which are free of nitrosamine contamination and which require further speciated testing.
The Automated Total Nitrosamine Analyser allows fully automated screening of samples down to low ppb levels.
Volatile Nitrosamine Analysis
Small molecule nitrosamines are some of the most common and controlled impurities. By using a detector designed specifically for nitrosamine analysis these compounds can be easily detected at low ppb levels.
The 800 Series TEA for GC is a detector that is highly selective and sensitive for nitrosamine compounds. Which is easily interfaced to most common GC systems.
Non-Volatile Nitrosamine Analysis
Many NDSRI's (Nitrosamine Drug Substance Related Impurities) are not volatile so GC analysis is not an option. Current techniques can be costly and struggle with limits of detection and false negatives.
The HPLC-TEA is a new detector that will offer a new approach to nitrosamine analysis. Offering sensitivity and selectivity for nitrosamine compounds.
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