Description

Methyl 2-Deoxy-D-Erythro-Pentopyranoside Bis(4-Methylbenzoate) (Decitabine Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the synthesis and analysis of the active pharmaceutical ingredient Decitabine, a vital nucleoside analog used in oncology. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Decitabine API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Decitabine meets stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various storage conditions.
• Process Chemistry R&D: Aids synthetic chemists in optimizing manufacturing processes to minimize the formation of this impurity.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.

Basic Information

Product Name	Methyl 2-Deoxy-D-Erythro-Pentopyranoside Bis(4-Methylbenzoate) (Decitabine Impurity)
CAS No.	78103-18-1
Molecular Formula	C22H24O7
Molecular Weight	400.42 g/mol
Synonyms	Methyl 2-Deoxy-D-erythro-pentopyranoside Bis(4-Methylbenzoate); 1-O-Methyl-2-deoxy-D-ribofuranose 3,5-di-p-toluate; Decitabine Related Compound; Decitabine Impurity; 2-Deoxy-D-ribofuranose, methyl 3,5-bis(4-methylbenzoate); Methyl 2-deoxy-3,5-di-O-(p-toluoyl)-D-ribofuranoside; p-Toluic Acid 2-Deoxy-3,5-di-O-(p-toluoyl)-D-ribofuranoside Methyl Ester
EINECS	Contact for details

Quality Control

Our Methyl 2-Deoxy-D-Erythro-Pentopyranoside Bis(4-Methylbenzoate) is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and specific impurity profiling. A comprehensive Certificate of Analysis (COA) detailing all test results is provided to support your regulatory and quality needs.

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 dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Residue on Ignition	≤ 0.1%

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