Description

Azacitidine Impurity 37 is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient Azacitidine. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in oncology drug development and regulatory compliance.

Application

• Primary use as a certified reference standard for the analytical method development and validation of Azacitidine.
• Critical component for impurity profiling and identification in Azacitidine API (Active Pharmaceutical Ingredient) batches.
• Used in stability studies to monitor the formation and levels of this impurity over time under various storage conditions.
• Essential for pharmacopeial testing to ensure compliance with stringent regulatory standards (e.g., USP, EP, ICH guidelines).
• Supports quality control (QC) and quality assurance (QA) processes in pharmaceutical manufacturing.
• Valuable for research and development into the degradation pathways and metabolism of Azacitidine.

Basic Information

Product Name	Azacitidine Impurity 37
CAS No.	206269-46-7
Molecular Formula	C8H12N4O5
Molecular Weight	244.21 g/mol
Synonyms	1-(2R,3R,4S,5R)-3,4-Dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-methoxy-1,3,5-triazin-2-one; 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one related compound; Azacitidine Related Compound; 1-(β-D-Ribofuranosyl)-4-methoxy-1,3,5-triazin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 37 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with each shipment to support your regulatory and quality documentation 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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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