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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 J

● Under Development

Catalogue No.:	VE0028009
CAS No.:	N/A
Mol. Formula:	C37H51N7O10
Mol. Weight:	753.84 g/mol

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Additional information on

Parent drug

Lisinopril

IUPAC Name

(S)-1-((S)-6-((S)-6-amino-2-(((S)-1-carboxy-3-phenylpropyl)(nitroso)amino)hexanamido)-2-(((S)-1-carboxy-3-phenylpropyl)(nitroso)amino)hexanoyl)pyrrolidine-2-carboxylic acid

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

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

InChI

InChI=1S/C37H51N7O10/c38-23-9-7-16-28(43(40-53)31(36(49)50)21-19-26-12-3-1-4-13-26)33(45)39-24-10-8-17-29(34(46)42-25-11-18-30(42)35(47)48)44(41-54)32(37(51)52)22-20-27-14-5-2-6-15-27/h1-6,12-15,28-32H,7-11,16-25,38H2,(H,39,45)(H,47,48)(H,49,50)(H,51,52)/t28-,29-,30?,31?,32?/m0/s1

Description

Dinitroso Lisinopril EP Impurity J is a process-related and potential degradation impurity characterized by nitroso functionality on the lisinopril scaffold. It can form via nitrosation when nitrite contaminants or nitrosating agents are present during synthesis or storage under acidic conditions. Analytical characterization relies on stability-indicating HPLC-UV and LC-MS methods supported by 1H and 13C NMR for structural confirmation. Control strategies include nitrite monitoring, optimized pH and quench steps, impurity-directed purification and validated removal in downstream processing. Risk assessment and specification setting for this nitroso impurity follow ICH Q3A and ICH M7 principles with validated quantitation limits.