Description

Azacitidine Impurity 31 is a specified impurity of the active pharmaceutical ingredient Azacitidine, a nucleoside metabolic inhibitor used in chemotherapy. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical laboratories and manufacturers in the pharmaceutical industry focused on ensuring the safety, efficacy, and regulatory compliance of Azacitidine-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Azacitidine Impurity 31 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure impurity levels are within specified limits, supporting Good Manufacturing Practice (GMP).
• Stability Studies: Employed to monitor the formation and growth of this impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry and process research to understand impurity formation pathways and optimize synthesis routes for purer API.

Basic Information

Product Name	Azacitidine Impurity 31
CAS No.	65024-85-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-amino-1,3,5-triazin-2-one; 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one; 1-β-D-Ribofuranosyl-4-amino-s-triazin-2(1H)-one; Azacitidine Related Compound; Azacitidine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 31 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure high purity and accurate identification, aligning with pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity, and impurities is provided and available upon request.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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