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Mumbai, India

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Documentation

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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

Tofacitinib Nitrosamine 1

● Under Development

Catalogue No.:	VE009892
CAS No.:	N/A
Mol. Formula:	C15H17N7O2
Mol. Weight:	327.34 g/mol

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Additional information on Tofacitinib Nitrosamine 1

Parent drug

Tofacitinib

IUPAC Name

N-(1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-(7H-pyrrolo[2, 3-d]pyrimidin-4-yl)nitrous amide

Synonyms

N-Nitroso N-desmethyl Tofacitinib

Smiles

O=NN(C1CN(C(CC#N)=O)CCC1C)C2=C3C(NC=C3)=NC=N2

InChI

InChI=1S/C15H17N7O2/c1-10-4-7-21(13(23)2-5-16)8-12(10)22(20-24)15-11-3-6-17-14(11)18-9-19-15/h3,6,9-10,12H,2,4,7-8H2,1H3,(H,17,18,19)

Description

Tofacitinib Nitrosamine 1 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.