Atropine EP Impurity D

Atropine EP Impurity D product with CAS: 55869-99-3; 55449-49-5 (HBr) is also known as 6-Hydroxy Hyoscyamine. 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 Atropine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 6-Hydroxy Hyoscyamine is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.