Description

Azacitidine Impurity 3 is a specified impurity of the active pharmaceutical ingredient Azacitidine, a critical nucleoside analog used in chemotherapy. This impurity is essential for pharmaceutical research and development, serving as a key reference standard for method development, validation, and quality control testing. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and biotechnology sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Azacitidine Impurity 3 in Azacitidine drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure drug substance and product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation and level of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Azacitidine synthesis pathway to minimize the formation of this specific impurity.

Basic Information

Product Name	Azacitidine Impurity 3
CAS No.	157771-77-2
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one; 1-(β-D-Ribofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one; 4-Amino-1-(β-D-ribofuranosyl)-1,3,5-triazin-2(1H)-one; Azacitidine Related Compound C; Azacitidine EP Impurity C; Azacitidine USP Related Compound C; Vidaza Impurity C
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. For long-term storage, consider storing at 2-8°C.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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