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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.

Dinitroso Lisinopril EP Impurity I

● Under Development

Catalogue No.:	VE0028011
CAS No.:	N/A
Mol. Formula:	C31H39N5O9
Mol. Weight:	625.37 g/mol

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Additional information on

Parent drug

Lisinopril

IUPAC Name

Dinitroso Lisinopril EP Impurity I

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

[H][C@@](N(N=O)[C@@]([H])(CCCCN(N=O)[C@]([H])(C(O)=O)CCC1=CC=CC=C1)C(N2CCC[C@]2(C(O)=O)[H])=O)(C(O)=O)CCC3=CC=CC=C3

InChI

InChI=1S/C31H39N5O9/c37-28(34-20-9-15-25(34)29(38)39)24(36(33-45)27(31(42)43)19-17-23-12-5-2-6-13-23)14-7-8-21-35(32-44)26(30(40)41)18-16-22-10-3-1-4-11-22/h1-6,10-13,24-27H,7-9,14-21H2,(H,38,39)(H,40,41)(H,42,43)/t24-,25?,26?,27?/m0/s1

Description

Dinitroso Lisinopril EP Impurity I is a characterized process-related impurity arising from nitrosation of the Lisinopril scaffold. Analytical characterization typically employs HPLC with UV detection, LC-MS for mass confirmation and NMR for structural assignment to establish identity and purity. Formation is commonly associated with residual nitrosating agents or oxidative conditions during synthesis or storage, prompting evaluation under forced degradation. Risk assessment focuses on low-level occurrence, control strategy and validated cleanup steps, including raw material control, pH management, scavengers and in-process monitoring. Robust analytical methods and specification-driven limits support regulatory compliance and impurity profile control for Lisinopril drug substance.