Loteprednol etabonate methyl ester

Loteprednol etabonate methyl ester product with CAS: NA is also known as (10R,11S,13S,17R)-methyl 17-(ethoxycarbonyloxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylate; Loteprednol Methyl ester. This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Loteprednol etabonate methyl ester is used in Loteprednol impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Loteprednol and its related formulations. Moreover, (10R,11S,13S,17R)-methyl 17-(ethoxycarbonyloxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylate 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 Loteprednol developed in our R&D.