Description

Decitabine Impurity 41 is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the safety and efficacy of the active pharmaceutical ingredient Decitabine by accurately identifying and quantifying related substances. It is primarily used by research institutions, quality control laboratories, and pharmaceutical companies involved in the development and production of oncology drugs. The availability of this well-characterized impurity supports regulatory compliance and robust impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Decitabine Impurity 41 in Decitabine drug substance and finished products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity data for drug master files.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize synthesis processes to minimize impurity formation.

Basic Information

Product Name	Decitabine Impurity 41
CAS No.	1442660-65-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(2-Deoxy-β-D-erythro-pentofuranosyl)-4-(methoxyamino)-2(1H)-pyrimidinone; 4-N-Methoxy-2'-deoxycytidine; 4-(Methoxyamino)-1-(2-deoxy-β-D-erythro-pentofuranosyl)-2(1H)-pyrimidinone; Decitabine Related Compound 41; Dacogen Impurity 41
EINECS	Contact for details

Quality Control

Every batch of Decitabine Impurity 41 is produced and analyzed under strict quality management protocols. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR) to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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