Description

Nitrosamine impurity for Torsemide product with CAS: NA is also known as N-(isopropylcarbamoyl)-4-(nitroso(m-tolyl)amino)pyridine-3-sulfonamide. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Nitrosamine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, N-(isopropylcarbamoyl)-4-(nitroso(m-tolyl)amino)pyridine-3-sulfonamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.

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