Description

Azacitidine Impurity 33 is a designated impurity of the active pharmaceutical ingredient Azacitidine, a nucleoside metabolic inhibitor used in chemotherapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Azacitidine drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Azacitidine API and finished dosage forms.
• Analytical Method Development: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch testing in GMP environments to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions and during shelf-life studies.
• Research & Development: Facilitates process chemistry research to understand and minimize impurity formation during Azacitidine synthesis.

Basic Information

Product Name	Azacitidine Impurity 33
CAS No.	1895868-05-9
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-1,2-dihydro-1,3,5-triazin-2-one; Azacitidine Related Compound 33; 5-Azacytidine Impurity 33; Ladakamycin Impurity 33; 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one related impurity; Azacitidine EP Impurity I; Azacitidine USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials qualified against USP/EP reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference retention time
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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