Description

Azacitidine Impurity 21 is a specified impurity of the active pharmaceutical ingredient Azacitidine, a nucleoside metabolic inhibitor used in chemotherapy. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical industry for method development, validation, and reference standard qualification.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Azacitidine drug substance and finished products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to separate and quantify impurities.
• Quality Control and Batch Release: Serves as a system suitability standard and for impurity profiling during the routine quality control testing of Azacitidine batches.
• Stability Studies: Employed to identify and track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in studies to understand the degradation pathways and chemical behavior of Azacitidine.

Basic Information

Product Name	Azacitidine Impurity 21
CAS No.	339091-26-8
Molecular Formula	C8H12N4O5
Molecular Weight	244.20 g/mol
Synonyms	1-(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-methoxy-1,2-dihydro-1,3,5-triazin-2-one; 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one Impurity; Azacitidine Related Compound 21; 5-Azacytidine Impurity 21; 1-(β-D-Ribofuranosyl)-1,4-dihydro-4-methoxy-1,3,5-triazin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 21 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using advanced techniques like HPLC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing all test results, including purity by HPLC and chromatographic purity, is provided with each shipment to support your regulatory and quality assurance needs.

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 must be kept under inert atmosphere or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to air.

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%
Chromatographic Purity (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.