Description

Cytarabine Impurity 6 CAS NO 69260-69-1 is a defined chemical impurity used as a reference standard in the pharmaceutical industry. Its primary value lies in ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Cytarabine, a critical chemotherapeutic agent. This compound is essential for analytical chemists and quality control laboratories in pharmaceutical manufacturing and regulatory testing who require high-purity materials for method development, validation, and routine impurity monitoring.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cytarabine Impurity 6 in Cytarabine API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in-house by API manufacturers and finished dosage form producers to ensure each batch meets stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Regulatory Submissions & Compliance: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and level of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Used in R&D laboratories to study the degradation pathways of Cytarabine and to synthesize impurity for toxicological studies.

Basic Information

Product Name	Cytarabine Impurity 6
CAS No.	69260-69-1
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosylcytosine N-Oxide; Ara-C N-Oxide; 1-(β-D-Arabinofuranosyl)-2(1H)-pyrimidinone; Cytosine Arabinoside N-Oxide; 2(1H)-Pyrimidinone, 1-β-D-arabinofuranosyl-; Cytarabine Related Compound F (USP); Cytarabine Impurity F
EINECS	Contact for details

Quality Control

Every batch of Cytarabine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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