Apixaban Amino Acid Impurity; Apixaban open ring acid impurity

Apixaban Amino Acid Impurity; Apixaban open ring acid impurity product with CAS: 2206825-87-6; 1188385-73-0 (14-C) is also known as Apixaban open lactam impurity. 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 Apixaban impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, Apixaban open lactam impurity is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.