Mometasone EP Impurity N

Mometasone EP Impurity N product with CAS: 352315-75-4 is also known as 9-Chloro-11β,17-dihydroxy-16α-methyl-3,20-dioxopregna-1,4-dien-21-yl methanesulfonate. 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 Mometasone impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 9-Chloro-11β,17-dihydroxy-16α-methyl-3,20-dioxopregna-1,4-dien-21-yl methanesulfonate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.