P-Methyl oxazolidone

P-Methyl oxazolidone product with CAS: NA is also known as (S)-1-(2-oxo-4-phenyloxazolidin-3-yl)-5-p-tolylpentane-1,5-dione. 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 Ezetimibe impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (S)-1-(2-oxo-4-phenyloxazolidin-3-yl)-5-p-tolylpentane-1,5-dione is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.