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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 G

● Under Development

Catalogue No.:	VE0028006
CAS No.:	N/A
Mol. Formula:	C42H58N8O11
Mol. Weight:	850.96 g/mol

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Additional information on

Parent drug

Lisinopril

IUPAC Name

(S)-1-((S)-6-((S)-2-(((S)-6-amino-1-((S)-2-carboxypyrrolidin-1-yl)-1-oxohexan-2-yl)(nitroso)amino)-4-phenylbutanamido)-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@](CCCCN)([H])C(N1CCC[C@]1(C(O)=O)[H])=O)(C(NCCCC[C@@](C(N(CCC2)[C@]2([H])C(O)=O)=O)(N(N=O)[C@]([H])(C(O)=O)CCC3=CC=CC=C3)[H])=O)CCC4=CC=CC=C4

InChI

InChI=1S/C42H58N8O11/c43-25-9-7-17-32(38(52)47-27-11-19-34(47)40(54)55)49(45-60)31(23-21-29-13-3-1-4-14-29)37(51)44-26-10-8-18-33(39(53)48-28-12-20-35(48)41(56)57)50(46-61)36(42(58)59)24-22-30-15-5-2-6-16-30/h1-6,13-16,31-36H,7-12,17-28,43H2,(H,44,51)(H,54,55)(H,56,57)(H,58,59)/t31-,32-,33-,34?,35?,36?/m0/s1

Description

Dinitroso Lisinopril EP Impurity G is a nitrosated degradation product observed in lisinopril API batches. Characterized as a dinitroso derivative, it arises from nitrosation of primary amine functionalities under nitrosating conditions during synthesis or storage. Analytical identification relies on high resolution LC-MS for accurate mass and fragmentation, HPLC for quantified assay and retention time, and NMR for structural confirmation. This impurity impacts impurity profile and requires establishment of qualification thresholds and validated limits in the EP monograph context. Control strategies include process parameter optimization, minimization of nitrite sources, in-process testing, and stability studies to ensure compliance with regulatory guidance on nitrosamine and related genotoxic impurities.