Description

Decitabine Impurity 2/((2R,3S,5R)-5-(4-Amino-2-Oxo-1,3,5-Triazin-1(2H)-Yl)-3-Hydroxytetrahydrofuran-2-Yl)Methyl 4-Methylbenzoate is a high-purity chemical reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient Decitabine. This compound is essential for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is primarily used by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) laboratories.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods in Decitabine manufacturing.
• Method Development & Validation: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor and control the levels of this specific impurity, ensuring final drug product meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Decitabine drug substance and drug products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Decitabine-related impurities.

Basic Information

Product Name	Decitabine Impurity 2/((2R,3S,5R)-5-(4-Amino-2-Oxo-1,3,5-Triazin-1(2H)-Yl)-3-Hydroxytetrahydrofuran-2-Yl)Methyl 4-Methylbenzoate
CAS No.	183016-22-0
Molecular Formula	C17H19N5O5
Molecular Weight	373.37 g/mol
Synonyms	Decitabine Related Compound 2; ((2R,3S,5R)-5-(4-Amino-2-oxo-1,3,5-triazin-1(2H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl 4-methylbenzoate; 5-Azacytidine Impurity; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one 5'-Benzoate Derivative; p-Toluic Acid ((2R,3S,5R)-5-(4-Amino-2-oxo-1,3,5-triazin-1(2H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl Ester
EINECS	Contact for details

Quality Control

This high-purity reference standard is manufactured under strict quality control conditions. Every batch is characterized using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, impurity profile, and analytical results. Our quality system is designed to support GMP-compliant applications and regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.