Description

Decitabine Impurity 6 (α-D-Erythro-Pentopyranoside-Methyl-2-Deoxy-Bis(4-Methylbenzoate)) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the quality control and regulatory compliance of Decitabine, an important antineoplastic agent. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure drug purity, safety, and efficacy. The availability of this well-characterized impurity standard is fundamental for method validation and meeting stringent global regulatory requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Decitabine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Decitabine to understand degradation pathways.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Utilized in synthetic chemistry research to study the formation and fate of process-related impurities during Decitabine manufacturing.

Basic Information

Product Name	Decitabine Impurity 6
CAS No.	78185-66-7
Molecular Formula	C22H24O8
Molecular Weight	416.42 g/mol
Synonyms	α-D-Erythro-Pentopyranoside-Methyl-2-Deoxy-Bis(4-Methylbenzoate); 1-(2-Deoxy-5-O-[(4-methylbenzoyl)oxy]-β-D-erythro-pentofuranosyl)-2-(4-methylbenzoyl)oxy-4(1H)-pyrimidinone; Decitabine Related Compound 6; Dacogen Impurity 6; 5-Aza-2'-deoxycytidine Impurity 6; 2'-Deoxy-5-azacytidine Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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