Description

Linezolid Diphthalimide product with CAS: 1798014-14-8 is also known as 2,2’-(3,3’-(3-Fluoro-4-morpholinophenylazanediyl)bis(2-hydroxypropane-3,1-diyl))diidoindoline-1,3-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 Linezolid impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 2,2’-(3,3’-(3-Fluoro-4-morpholinophenylazanediyl)bis(2-hydroxypropane-3,1-diyl))diidoindoline-1,3-dione 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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