Nitrosamine Impurity Analysis-Achieving Compliance through Chromeleon CDS for GC-MS.

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“Nitrosamine” is an organic compound; structurally Contents R2N–N=O where ‘R’ is usually alkyl group, Nitrosamine usually produced by the reaction of nitrous acid (HNO2) with a secondary amine. Nitrosamine mainly presents in dairy products, vegetables, food items like grilled meat and water.

The pharma business has been affected worldwide because the presence of Nitrosamine impurities was found in different medication substances, for example, valsartan and ranitidine by the US FDA and EMA. 


    As per new US FDA and EMA guidelines, medicine manufactures of Angiotensin-receptor blockers (ARBs) or sartans must recheck that their generic sartans should contain no quantifiable degrees of nitrosamine contaminations after a specific progress period. 

    Thermo Scientific™ Chromeleon™ 7.3 Chromatography Data System (CDS), along with our top-notch systematic instrumentation, offers noteworthy profitability advances to the research center (up to 33%*)

We are surrounded by the presence of Nitrosamine in various routine items but nitrosamine impurities may increase the risk of cancer if we exposed more than the accepted level over a long period of time. But if we take in nitrosamine less than the threshold level then we can use up to 70 years of lifespan without an increased risk of cancer. 

Patients taking these medications containing the presence of nitrosamine should not stop medication without concern with their physician, if more amount traces are detected in medication then surely change and take another substitute of that particular medication.




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