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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

N-((1S,2R,5S)-1-(4-(benzyloxy)phenyl)-5-(4-fluorophenyl)-5-hydroxy-2-((S)-2-oxo-4-phenyloxazolidine-3-carbonyl)pentyl)-N-(4-fluorophenyl)nitrous amide

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Catalogue No.:	VE0026228
CAS No.:	N/A
Mol. Formula:	C40H35F2N3O6
Mol. Weight:	691.72 g/mol

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Additional information on

Parent drug

Ezetimibe

IUPAC Name

N-((1S,2R,5S)-1-(4-(benzyloxy)phenyl)-5-(4-fluorophenyl)-5-hydroxy-2-((S)-2-oxo-4-phenyloxazolidine-3-carbonyl)pentyl)-N-(4-fluorophenyl)nitrous amide

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

O=NN([C@H](C1=CC=C(OCC2=CC=CC=C2)C=C1)[C@H](C(N3C(OC[C@@H]3C4=CC=CC=C4)=O)=O)CC[C@@H](C5=CC=C(F)C=C5)O)C6=CC=C(F)C=C6

InChI

InChI=1S/C40H35F2N3O6/c41-31-15-11-29(12-16-31)37(46)24-23-35(39(47)44-36(26-51-40(44)48)28-9-5-2-6-10-28)38(45(43-49)33-19-17-32(42)18-20-33)30-13-21-34(22-14-30)50-25-27-7-3-1-4-8-27/h1-22,35-38,46H,23-26H2/t35-,36-,37+,38-/m1/s1

Description

N-((1S,2R,5S)-1-(4-(benzyloxy)phenyl)-5-(4-fluorophenyl)-5-hydroxy-2-((S)-2-oxo-4-phenyloxazolidine-3-carbonyl)pentyl)-N-(4-fluorophenyl)nitrous amide impurity is a stereochemically complex synthetic byproduct that can arise from incomplete acylation, transamidation or side reactions during oxazolidinone assembly and benzyl ether manipulations. It exhibits increased polarity relative to the parent API and may coelute with late-eluting peaks, challenging chromatographic resolution. Reliable detection and quantitation require orthogonal techniques such as reversed-phase UHPLC-MS, chiral HPLC and quantitative NMR supported by HRMS and IR fingerprinting. Control strategies include reaction stoichiometry optimization, targeted purification steps, validated in-process controls and specification-driven limits to mitigate impact on potency, stability and safety profiles.