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Enthält: HPLC, MASS/LC-MS, 1H-NMR, FT-IR, Gehalt, Structure Elucidation Report (SER) sowie zusätzliche analytische Daten je nach Produkt.

Irbesartan Nitroso Impurity 1

● Under Development

Katalog-Nr.::	VE006176
CAS-Nr.::	N/A
Summenformel::	C25H27N7O2
Molare Masse::	457.53

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Zusätzliche Informationen zu Irbesartan Nitroso Impurity 1

Parent drug

Irbesartan

IUPAC-Name

2-butyl-3-((2′-(1-nitroso-1H-tetrazol-5-yl)-[1, 1′-biphenyl]-4-yl)methyl)-1, 3-diazaspiro[4.4]non-1-en-4-one

Synonyme

Irbesartan Impurity 17

SMILES

O=C1N(CC2=CC=C(C3=CC=CC=C3C4=NN=NN4N=O)C=C2)C(CCCC)=NC15CCCC5

InChI

InChI=1S/C25H27N7O2/c1-2-3-10-22-26-25(15-6-7-16-25)24(33)31(22)17-18-11-13-19(14-12-18)20-8-4-5-9-21(20)23-27-28-29-32(23)30-34/h4-5,8-9,11-14H,2-3,6-7,10,15-17H2,1H3

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Beschreibung

Irbesartan Nitroso Impurity 1 is an N-nitroso derivative of the secondary amine present in Irbesartan | 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 Irbesartan 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.