Description

Cytarabine Impurity 12 is a specified impurity and degradation product of the critical antineoplastic agent Cytarabine. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Cytarabine drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Cytarabine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B guidelines) for specified impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides essential data for regulatory filings (IND, NDA, ANDA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis or storage of Cytarabine, enabling process optimization.

Basic Information

Product Name	Cytarabine Impurity 12
CAS No.	14057-18-2
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosyluracil; Ara-U; Uracil arabinoside; 1-(β-D-Arabinofuranosyl)uracil; Spongouridine; Uridine, 2'-deoxy-; Cytarabine related compound
EINECS	Contact for details

Quality Control

Every batch of Cytarabine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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