Description

Decitabine Impurity 28 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Decitabine, a vital medication in oncology. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. The availability of this well-characterized impurity is essential for meeting stringent regulatory compliance in drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Decitabine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing of Decitabine batches to ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Supports synthetic chemistry research aimed at understanding and minimizing impurity formation during the manufacturing process.

Basic Information

Product Name	Decitabine Impurity 28
CAS No.	570410-68-3
Molecular Formula	C8H12N4O4
Molecular Weight	228.21 g/mol
Synonyms	1-(2-Deoxy-β-D-erythro-pentofuranosyl)-5-azacytosine; 5-Aza-2'-deoxycytidine Impurity 28; 5-Aza-dC Impurity 28; Dacogen Impurity 28; 1-(2-Deoxy-β-D-ribofuranosyl)-5-azacytosine; 4-Amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 28 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use as a reference standard in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%

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