Timolol Nitrosamine

Timolol Nitrosamine product with CAS: NA is also known as (S)-N-tert-butyl-N-(2-hydroxy-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propyl)nitrous amide. 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 Timolol impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (S)-N-tert-butyl-N-(2-hydroxy-3-(4-morpholino-1,2,5-thiadiazol-3-yloxy)propyl)nitrous amide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.