Description

Cytarabine Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Cytarabine, a key chemotherapeutic agent. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cytarabine drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Serves as a system suitability standard in QC labs to ensure analytical procedures are performing correctly for impurity detection.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Cytarabine formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and chemical behavior of Cytarabine.

Basic Information

Product Name	Cytarabine Impurity 13
CAS No.	82855-62-7
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; Cytosine Arabinoside 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 13 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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