Description

Azacitidine Impurity 20 is a specified impurity of the active pharmaceutical ingredient (API) Azacitidine, a nucleoside metabolic inhibitor used in chemotherapy. This impurity is a critical reference standard for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require high-purity chemical standards to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Azacitidine Impurity 20 in Azacitidine API and finished drug products.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions during drug product shelf-life studies.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Azacitidine.

Basic Information

Product Name	Azacitidine Impurity 20
CAS No.	89618-11-1
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 4-N-oxide; Azacitidine N-Oxide Impurity; Azacitidine Related Compound 20; Vidaza Impurity 20
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 conditions (e.g., nitrogen atmosphere) for long-term storage to prevent degradation. Allow the sealed container to reach ambient temperature before opening to minimize moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.