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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 Tofacitinib

● Failure Report (NAP Test) Available

Katalog-Nr.::	VE009521
CAS-Nr.::	N/A
Summenformel::	C16H19N7O2
Molare Masse::	341.4 g//mol

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Zusätzliche Informationen zu N-Nitroso Tofacitinib

Parent drug

Tofacitinib

IUPAC-Name

3-((3R, 4R)-4-methyl-3-(methyl(7-nitroso-7H-pyrrolo[2, 3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile

Pharmakopöe-Synonyme

Tofacitinib Nitroso Impurity 1

Other Synonyms

N/A

SMILES

N#CCC(N1C[C@H](N(C)C2=C3C(N(N=O)C=C3)=NC=N2)[C@H](C)CC1)=O

InChI

InChI=1S/C16H19N7O2/c1-11-4-7-22(14(24)3-6-17)9-13(11)21(2)15-12-5-8-23(20-25)16(12)19-10-18-15/h5,8,10-11,13H,3-4,7,9H2,1-2H3/t11-,13+/m1/s1

Beschreibung

N-Nitroso Tofacitinib is an N-nitroso derivative of the secondary amine present in Tofacitinib 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 Tofacitinib 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 Tofacitinib: Synthesis Attempts and Failure Report (NAP Test)