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Documentation

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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.

Letermovir N2-Oxide Impurity

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Catalogue No.:	VE0026652
CAS No.:	N/A
Mol. Formula:	C29H28F4N4O5
Mol. Weight:	588.55 g/mol

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Additional information on

Parent drug

Letermovir

IUPAC Name

(S)-1-(4-(carboxymethyl)-8-fluoro-3-(2-methoxy-5-(trifluoromethyl)phenyl)-3,4-dihydroquinazolin-2-yl)-4-(3-methoxyphenyl)piperazine 1-oxide

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

COC1=CC(N2CC[N+](C3=NC4=C(C=CC=C4F)[C@H](CC(O)=O)N3C5=CC(C(F)(F)F)=CC=C5OC)([O-])CC2)=CC=C1

InChI

InChI=1S/C29H28F4N4O5/c1-41-20-6-3-5-19(16-20)35-11-13-37(40,14-12-35)28-34-27-21(7-4-8-22(27)30)23(17-26(38)39)36(28)24-15-18(29(31,32)33)9-10-25(24)42-2/h3-10,15-16,23H,11-14,17H2,1-2H3,(H,38,39)/t23-/m0/s1

Description

Letermovir N2-Oxide impurity is an oxidative degradation product formed via N-oxidation of the letermovir amine moiety, and it merits monitoring within the impurity profile due to potential impacts on potency and safety. Characterization typically employs LC-MS and HPLC with a stability indicating method to determine retention time, mass spectral features and UV response. Forced degradation studies under oxidative and thermal stress help define formation pathways and facilitate specification setting in line with ICH Q3A/B guidelines. Control strategies include antioxidant additives, inert processing atmosphere and optimized purification steps to limit formation, supported by validated quantitation methods and documented qualification thresholds.