O-Desmethyl Brinzolamide Impurity

O-Desmethyl Brinzolamide Impurity product with CAS: 186377-56-0 is also known as (R)-4-(Ethylamino)-3,4-dihydro-2-(3-hydroxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide. 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 Brinzolamide impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (R)-4-(Ethylamino)-3,4-dihydro-2-(3-hydroxypropyl)-2H-thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.