Description

Decitabine Impurity 8 is a specified impurity and degradation product of the active pharmaceutical ingredient Decitabine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for laboratories and manufacturers in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Decitabine API and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Decitabine.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and specifications.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving synthesis processes.

Basic Information

Product Name	Decitabine Impurity 8
CAS No.	157771-78-3
Molecular Formula	C8H12N4O4
Molecular Weight	228.21 g/mol
Synonyms	4-Amino-1-[(2R,3S,4R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2-one; 1-(2-Deoxy-β-D-ribofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one; Dihydro-5-azacytidine Impurity; 5-Aza-2'-deoxycytidine Related Compound; DAC Impurity 8
EINECS	Contact for details

Quality Control

Our Decitabine Impurity 8 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous demands of pharmaceutical reference material applications.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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