Description

Decitabine Impurity 3 is a critical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Decitabine. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in the research, development, and quality assurance processes for oncology drugs, specifically for the accurate identification and quantification of process-related impurities.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Used in HPLC, LC-MS, and other chromatographic analyses to monitor and control impurity levels in Decitabine API batches.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization.
• Method Development & Validation: Employed by R&D scientists to develop, optimize, and validate stability-indicating assay methods for Decitabine.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of drug products.
• Contract Research & Manufacturing (CRO/CMO): A vital material for organizations providing analytical testing and manufacturing services to the pharmaceutical industry.

Basic Information

Product Name	Decitabine Impurity 3
CAS No.	113476-23-6
Molecular Formula	C8H12N4O4
Molecular Weight	228.21 g/mol
Synonyms	4-Amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one; 5-Azacytidine Impurity; 5-Aza-2'-deoxycytidine Related Compound; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one; DAC Impurity; Dezocitidine Impurity
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications and support compliance with ICH Q3A/B guidelines.

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 material 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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