Description

Decitabine Impurity 7 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Decitabine. This compound is critical for ensuring the purity, safety, and efficacy of Decitabine, a vital chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions involved in the development, production, and regulatory compliance of oncology drugs.

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 & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and system precision standard in routine batch release testing to monitor impurity levels against pharmacopeial limits.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for Drug Master Files (DMFs) and Common Technical Documents (CTDs).
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (forced degradation studies).
• Research & Development (R&D): Used in synthetic chemistry and process development to understand and control impurity formation pathways during Decitabine synthesis.

Basic Information

Product Name	Decitabine Impurity 7
CAS No.	20535-28-8
Molecular Formula	C8H12N4O4
Molecular Weight	228.21 g/mol
Synonyms	4-Amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one; 5-Azacytidine Impurity; 5-Aza-2'-deoxycytidine related compound; 1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-amino-1,3,5-triazin-2(1H)-one; DAC Impurity 7; 5-AZA-CdR Impurity
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC, NMR, and Mass Spectrometry 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 at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 1.0%
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.