Description

Linezolid Diphthalimide Methyl Carbamate Dimer product with CAS: NA is also known as 3,3′-(3-fluoro-4-morpholinophenylazanediyl)bis(1-(1,3-dioxoisoindolin-2-yl)propane-3,2-diyl) dimethyl dicarbonate. 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 Linezolid impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 3,3′-(3-fluoro-4-morpholinophenylazanediyl)bis(1-(1,3-dioxoisoindolin-2-yl)propane-3,2-diyl) dimethyl dicarbonate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.

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