It is applied as a certified impurity standard (e.g. Dapagliflozin Impurity 76 Glucuronic Acid Impurity 4 Empagliflozin Impurity) in HPLCanalytical method validation stability studies and quality control for SGLT2 inhibitors and related APIs.

Its primary purpose is enabling detection identification and quantification of process-related impurities during drug synthesis to ensure purity compliance with ICHUSP guidelines while also functioning as a mild acidulant and sequestrant in foodpharm

L-Glucono-15-lactone (CAS 52153-09-0) also known as L-gluconolactone or L-glucono-delta-lactone is a white to off-white crystalline solid (CHO MW 178.14 gmol) that serves as a key analytical impurity reference standard in pharmaceutical testing for drugs like empagliflozin dapagliflozin and glucuronic acid derivatives with a melting point of 142-144C and limited solubility in waterDMSO.