Description

Decitabine Impurity (Ring-Opening) is a critical pharmaceutical reference standard used for analytical and research purposes. This compound is specifically employed in the quality control and method development for the antineoplastic drug Decitabine, ensuring product safety and regulatory compliance. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on oncology drug development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of the ring-opened impurity in Decitabine API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Decitabine meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., hydrolysis, thermal).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) documents by providing impurity characterization data.
• Research & Development: Facilitates studies on the degradation pathways, kinetics, and toxicological profile of Decitabine-related substances.

Basic Information

Product Name	Decitabine Impurity (Ring-Opening)
CAS No.	69304-64-9
Molecular Formula	C8H12N4O4
Molecular Weight	228.21 g/mol
Synonyms	4-Amino-1-[(2R,3S,4S,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; Decitabine Ring-Opened Degradant; 5-Azacytidine Ring-Opening Impurity; DAC Impurity A (Ring-Opened Form); 4-Amino-1-(2-deoxy-β-D-ribofuranosyl)-1,3,5-triazin-2(1H)-one
EINECS	Contact for details

Quality Control

Our Decitabine Impurity (Ring-Opening) is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
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.