Description

Cytarabine Impurity 4 is a specified impurity of the antineoplastic drug Cytarabine, used in pharmaceutical quality control and analytical research. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cytarabine Impurity 4 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Cytarabine API.
• Quality Control & Assurance (QC/QA): A critical component in the quality control testing of Cytarabine to ensure it meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in synthetic chemistry and pharmacokinetic studies to understand the degradation pathways and metabolism of Cytarabine.

Basic Information

Product Name	Cytarabine Impurity 4
CAS No.	18265-49-1
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosylcytosine N1-Oxide; Ara-C N1-Oxide; Cytarabine N1-Oxide; Uridine, 4-amino-1-β-D-arabinofuranosyl-, 1-oxide; 4-Amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone 1-Oxide
EINECS	Contact for details

Quality Control

Every batch of Cytarabine Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation by NMR and MS, to ensure compliance with high-grade reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
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.