Description

Decitabine Impurity 6 CAS NO 178671-74-4 is a high-purity chemical reference standard used for the identification and quantification of process-related impurities in the active pharmaceutical ingredient Decitabine. This compound is critical for ensuring the quality, safety, and regulatory compliance of Decitabine, a vital chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and quality control units for method development, validation, and routine batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical testing of Decitabine API and finished drug products.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Decitabine formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Used in process chemistry R&D to understand and minimize impurity formation during synthesis.

Basic Information

Product Name	Decitabine Impurity 6
CAS No.	178671-74-4
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; 5-Azacytidine Impurity; 5-Aza-2'-deoxycytidine Related Compound; DAC Impurity; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.