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포함 사항: HPLC, MASS/LC-MS, 1H NMR, FT-IR, 함량, 구조 규명 보고서(SER), 그리고 제품에 따라 추가 분석 데이터가 제공됩니다.

Lisinopril EP Impurity G Nitroso 1

● Under Development

카탈로그 번호:	VE0028002
CAS 번호:	N/A
분자식:	C42H59N7O10
분자량:	821.96 g/mol

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모약물

Lisinopril

IUPAC명

(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)amino)hexanoyl)pyrrolidine-2-carboxylic acid

Pharmacopeial Synonyms

N/A

동의어

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[C@]([H])(C(O)=O)CCC3=CC=CC=C3)[H])=O)CCC4=CC=CC=C4

InChI

InChI=1S/C42H59N7O10/c43-25-9-7-18-34(39(52)48-28-12-20-36(48)42(57)58)49(46-59)33(24-22-30-15-5-2-6-16-30)37(50)44-26-10-8-17-31(38(51)47-27-11-19-35(47)41(55)56)45-32(40(53)54)23-21-29-13-3-1-4-14-29/h1-6,13-16,31-36,45H,7-12,17-28,43H2,(H,44,50)(H,53,54)(H,55,56)(H,57,58)/t31-,32?,33-,34-,35?,36?/m0/s1

설명

Lisinopril EP Impurity G Nitroso 1 is a nitroso-type process impurity encountered in lisinopril synthesis and stability profiles, formed via nitrosation of amine precursors or exposure to nitrosating agents during manufacturing or storage. Analytical characterization relies on high-resolution LC-MS/MS and validated HPLC-UV assays with trace-level quantitation using solid-phase extraction or SPE cleanup. Because nitroso moieties carry potential genotoxic concern, identification, structural elucidation and control strategies are essential for regulatory compliance under ICH M7 and nitrosamine guidance. Mitigation focuses on nitrite control, pH management, scavengers and validated cleaning validation. Detailed impurity profile, retention behavior and MS fragmentation data available for method development and quality risk assessment.