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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.

Dinitroso Palbociclib

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Catalogue No.:	VE0015659
CAS No.:	N/A
Mol. Formula:	C24H27N9O4
Mol. Weight:	505.05 g/mol

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Additional information on Dinitroso Palbociclib

Parent drug

Palbociclib

IUPAC Name

N-(6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)-N-(5-(4-nitrosopiperazin-1-yl)pyridin-2-yl)nitrous amide

Pharmacopoeial Synonyms

N/A

Other Synonyms

Palbociclib Nitroso Impurity 2

Smiles

O=NN(C1=NC=C(C(C)=C(C(C)=O)C(N2C3CCCC3)=O)C2=N1)C4=NC=C(N5CCN(N=O)CC5)C=C4

InChI

InChI=1S/C24H27N9O4/c1-15-19-14-26-24(27-22(19)32(17-5-3-4-6-17)23(35)21(15)16(2)34)33(29-37)20-8-7-18(13-25-20)30-9-11-31(28-36)12-10-30/h7-8,13-14,17H,3-6,9-12H2,1-2H3

Description

Dinitroso Palbociclib, also designated Palbociclib Nitroso Impurity 2, is a nitroso-derived process-related impurity associated with the palbociclib scaffold and structurally consistent with nitrosamine-like functionality. With molecular formula C24H27N9O4 and molecular weight 505.05 g/mol, it represents a chemically distinct oxidation and nitrosation product that may arise during synthesis or from nitrosating conditions applied to amine-containing intermediates. Such species are evaluated under ICH M7 because nitroso impurities may present mutagenic concern. Trace-level determination typically requires LC-MS/MS, high-resolution LC-MS, and, where appropriate, targeted GC-MS confirmation.