Description

Decitabine Deformyl Impurity CAS NO 69304-65-0 is a critical reference standard and process impurity used in the pharmaceutical development and quality control of Decitabine, an important antineoplastic agent. This compound is essential for ensuring the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and biotechnology sectors for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Decitabine.
• Impurity Profiling & Identification: Critical for identifying and quantifying the deformyl impurity in Decitabine API and finished drug products during stability and release testing.
• Method Development & Validation: Serves as a key component in developing and validating analytical methods, particularly HPLC and LC-MS, for impurity detection.
• Process Chemistry Research: Used in research to understand and optimize the synthesis pathway of Decitabine, helping to minimize the formation of this specific impurity.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity levels as per ICH Q3A and Q3B guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity specifications are met.

Basic Information

Product Name	Decitabine Deformyl Impurity
CAS No.	69304-65-0
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 Deformyl Impurity; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-s-triazin-2(1H)-one; DAC Deformyl Impurity; 2'-Deoxy-5-azacytidine Deformyl Impurity; Dezocitabine Deformyl Impurity
EINECS	Contact for details

Quality Control

Every batch of Decitabine Deformyl Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided to support your regulatory and analytical needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
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.