Atropine EP Impurity E

Atropine EP Impurity E product with CAS: 949092-65-3 is also known as 7-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, 7-Hydroxy Hyoscyamine is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.