Description

Decitabine Impurity 4 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Decitabine. This compound is critical for ensuring the quality, safety, and efficacy of Decitabine, a vital chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Decitabine Impurity 4 in Decitabine drug substance and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Stability Studies: Employed in routine batch release testing and forced degradation studies to monitor impurity levels and ensure product stability.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Utilized in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.
• Pharmacopeial Testing: Applied as a system suitability standard in testing to meet USP, EP, or other pharmacopeia monograph requirements for Decitabine.

Basic Information

Product Name	Decitabine Impurity 4
CAS No.	863396-35-4
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; 4-Amino-1-(2-deoxy-β-D-ribofuranosyl)-1,3,5-triazin-2(1H)-one; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one; DAC Impurity 4; 5-Azacytidine Impurity; 5-Aza-2'-deoxycytidine Related Compound
EINECS	Contact for details

Quality Control

Our Decitabine Impurity 4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (IR, NMR), purity assay (HPLC), and related substance analysis. We adhere to industry best practices and can support compliance with relevant pharmacopeial standards (USP, EP) upon request.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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