Description

Decitabine Impurity 2 (β-Isomer) is a specific stereoisomeric impurity associated with the pharmaceutical active ingredient Decitabine, a nucleoside analog used in chemotherapy. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is primarily required by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Decitabine-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified reference material (CRM) for the identification and quantification of the β-isomer impurity in Decitabine drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately separate and measure process-related impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity profiles and ensure compliance with strict pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., FDA, EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Decitabine to minimize the formation of this isomer during manufacturing.

Basic Information

Product Name	Decitabine Impurity 2 (β-Isomer)
CAS No.	78185-65-6
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-Aza-2'-deoxycytidine β-Isomer; 5-Aza-dC β-Isomer; DAC Impurity 2; Dezocitidine Impurity 2; (2'R)-2'-Deoxy-5-azacytidine; β-5-Aza-2'-Deoxycytidine
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 2 (β-Isomer) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including chromatographic purity, water content, and residual solvents, in alignment with ICH 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 must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
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.