Description

Decitabine Impurity 4 (Methyl 2-Deoxy-β-D-Ribopyranoside) is a critical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Decitabine. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, quality assurance departments, and research scientists within the pharmaceutical and biotechnology sectors for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical testing of Decitabine API and finished drug products.
• Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC batch release testing to ensure impurity levels are within specified pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: A key marker for monitoring the degradation profile of Decitabine under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Decitabine Impurity 4 (Methyl 2-Deoxy-β-D-Ribopyranoside)
CAS No.	17676-20-9
Molecular Formula	C6H12O4
Molecular Weight	148.16 g/mol
Synonyms	Methyl 2-Deoxy-β-D-ribopyranoside; Methyl 2-Deoxy-β-D-riboside; 2-Deoxy-β-D-ribopyranoside Methyl Ether; Methyl 2-Deoxy-β-D-ribofuranoside (tautomer); Decitabine Related Compound; Decitabine Impurity D (potential designation); 2-Deoxy-β-D-ribose Methyl Glycoside; β-Methyl 2-Deoxyriboside
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

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 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.