Decitabine Impurity 34

Development, validation, and clinical application of a high-performance liquid chromatography-tandem mass spectrometry assay for the quantifica0074ion of total intracellular -decitabine nucleotides and genomic DNA incorporated -decitabine and 5-methyl-2 -deoxycytidine
Jeroen Roosendaal , Hilde Rosinga, Luc Lucas a, Aram Oganesianc, Jan H.M. Schellens b,d,e, Jos H. Beijnen
Journal of Pharmaceutical and Biomedical Analysis 164 (2019) 16–26
 
Isolation, characterization, and properties of a labile hydrolysis product of the antitumor nucleoside, 5-azacytidine
John A. Beisler
J. Med. Chem. 1978, 21, 2, 204–208
 
Stability indicating RP-HPLC Method Devlopment and Validation of Decitabine Drug in Formulation
Glory hepsiba1 *, Dr.B.B.Teja2 , K.Ashok kumar1 , Y.Ravindra reddy
International Journal of PharmTech Research CODEN (USA): IJPRIF Vol. 3, No.1, pp 237-243,

Decitabine Impurity 34 is chemically (2R,3S,5S)-5-(4-Amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(((4-methylbenzoyl)oxy)methyl)tetrahydrofuran-3-yl 4-methylbenzoate. It is also known as Alpha Di-tolyl impurity . Decitabine Impurity 34 is supplied with detailed characterization data compliant with regulatory guideline. Decitabine Impurity 34 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Decitabine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.