Description

N-Nitroso Pregabalin product with CAS: NA is also known as (S)-5-methyl-3-(nitrosoamino)hexanoic acid. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. N-Nitroso Pregabalin is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Pregabalin and its related formulations. Moreover, (S)-5-methyl-3-(nitrosoamino)hexanoic acid 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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