Description

Canagliflozin Dimer Impurity product with CAS: NA is also known as (2S,3R,4S,5S,6R)-2-(3-((5-(4-Fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-2-(((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methoxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Canagliflozin Dimer Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Canagliflozin and its related formulations. Moreover, (2S,3R,4S,5S,6R)-2-(3-((5-(4-Fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-2-(((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro-2H-pyran-2-yl)methoxy)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol 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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