Ipratropium EP Impurity A

Ipratropium EP Impurity A product with CAS: 58005-18-8 is also known as (8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide; (3-endo,8-syn)-3-Hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane Bromide (1:1). This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Ipratropium EP Impurity A is used in Ipratropium Bromide impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Ipratropium Bromide and its related formulations. Moreover, (8R)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium Bromide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Ipratropium Bromide developed in our R&D.