title: Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP.
abstract: An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS, and UV) techniques as the structurally-related compound Monacolin-X, having the molecular formula C24H34O6 and the chemical name 2-methyl-3-oxobutanoic acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl ester.
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Chandrakant
authors.initials: C
authors.lastname: Belwal
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Praveen Kumar
authors.initials: PK
authors.lastname: Goyal
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Anup
authors.initials: A
authors.lastname: Balte
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kolhe
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Chauhan
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Ajay Singh
authors.initials: AS
authors.lastname: Rawat
authors.affiliation: Sterling Biotech Research Centre, Sterling Biotech Limited, Vadodara-391421, India.
authors.forename: Anand
authors.initials: A
authors.lastname: Vardhan
keywords: Characterization; Chromatography; Identification; Isolation; Lovastatin; Prep HPLC