Description

Azacitidine Impurity 34 is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient Azacitidine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in the development, validation, and routine testing of Azacitidine, a key chemotherapeutic agent.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Azacitidine API and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Azacitidine.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during process development.

Basic Information

Product Name	Azacitidine Impurity 34
CAS No.	105330-94-7
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-1,2-dihydro-1,3,5-triazin-2-one; 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one Impurity; Azacitidine Related Compound 34; Ladakamycin Impurity 34; 5-Azacytidine Impurity 34; NSC-102816 Impurity
EINECS	Contact for details

Quality Control

Every batch of Azacitidine Impurity 34 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, NMR, and mass spectrometry to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Rotation	Contact for details

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