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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.

N-Nitroso Eltrombopag Amino Impurity

● Failure Report (NAP Test) Available

Katalog-Nr.::	VE0024456
CAS-Nr.::	N/A
Summenformel::	C13H10N2O4
Molare Masse::	258.23 g/mol

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Zusätzliche Informationen zu N-Nitroso Eltrombopag Amino Impurity

Parent drug

Eltrombopag

IUPAC-Name

2′-hydroxy-3′-(nitrosoamino)-[1, 1′-biphenyl]-3-carboxylic acid

Pharmakopöe-Synonyme

N/A

Other Synonyms

N/A

SMILES

O=C(O)C1=CC(C2=CC=CC(NN=O)=C2O)=CC=C1

InChI

InChI=1S/C13H10N2O4/c16-12-10(5-2-6-11(12)14-15-19)8-3-1-4-9(7-8)13(17)18/h1-7, 16H, (H, 14, 19)(H, 17, 18)

Beschreibung

N-Nitroso Eltrombopag Amino Impurity is an N-nitroso derivative of the secondary amine present in Eltrombopag, 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 Eltrombopag 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.

N-Nitroso-Eltrombopag Amino-Impurity: Synthesis Attempts and Failure Report (NAP Test)