1797419-58-9N-Desmethyl Rosuvastatin Lactone (Free Base)

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Catalogue No.:	VE0026527
CAS No.:	1797419-58-9
Mol. Formula:	C21H24FN3O5S
Mol. Weight:	449.5 g/mol

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Additional information on CAS 1797419-58-9

Parent drug

Rosuvastatin

IUPAC Name

N-[4-(4-fluorophenyl)-5-[(E)-2-[(2S,4R)-4-hydroxy-6-oxooxan-2-yl]ethenyl]-6-propan-2-ylpyrimidin-2-yl]methanesulfonamide

Pharmacopeial Synonyms

N/A

Synonyms

N-desmethyl Rosuvastatin-5S-lactone

Smiles

CC(C)C1=NC(=NC(=C1/C=C/[C@@H]2C[C@H](CC(=O)O2)O)C3=CC=C(C=C3)F)NS(=O)(=O)C

InChI

InChI=1S/C21H24FN3O5S/c1-12(2)19-17(9-8-16-10-15(26)11-18(27)30-16)20(13-4-6-14(22)7-5-13)24-21(23-19)25-31(3,28)29/h4-9,12,15-16,26H,10-11H2,1-3H3,(H,23,24,25)/b9-8+/t15-,16-/m1/s1

Description

N-Desmethyl Rosuvastatin Lactone (CAS 1797419-58-9), also known as N-desmethyl Rosuvastatin-5S-lactone, is a structurally related pharmaceutical impurity formed through metabolic or degradation pathways of rosuvastatin derivatives. This impurity is critical for quality control and regulatory assessment because its presence can influence drug potency, stability, and safety profiles. Analytical characterization using HPLC, LC-MS and NMR enables precise identification and quantification during stability studies and batch release testing. Profiling formation mechanisms, chromatographic retention behavior and acceptable impurity limits supports robust impurity control strategies and risk assessment in drug substance manufacturing and formulation development.