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N-Nitroso Lisinopril EP Impurity E

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Katalog-Nr.::	VE0011216
CAS-Nr.::	N/A
Summenformel::	C21H30N4O6
Molare Masse::	434.5 g/mol

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Zusätzliche Informationen zu N-Nitroso Lisinopril EP Impurity E

Parent drug

Lisinopril

IUPAC-Name

N2-((R)-1-carboxy-3-phenylpropyl)-N2-nitroso-L-lysyl-L-proline

Pharmacopeial Synonyms

N/A

Other Synonyms

N-Nitroso Lisinopril (R,S,S)-Isomer

SMILES

O=C(O)[C@H]1N(C([C@H](CCCCN)N([C@@H](C(O)=O)CCC2=CC=CC=C2)N=O)=O)CCC1

InChl

InChI=1S/C21H30N4O6/c22-13-5-4-9-16(19(26)24-14-6-10-17(24)20(27)28)25(23-31)18(21(29)30)12-11-15-7-2-1-3-8-15/h1-3,7-8,16-18H,4-6,9-14,22H2,(H,27,28)(H,29,30)/t16-,17-,18+/m0/s1

Beschreibung

N-Nitroso Lisinopril EP Impurity E is an N-nitroso derivative of the secondary amine present in Lisinopril | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Lisinopril production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.