Description

Clofarabine Impurity 14 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Clofarabine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for identification and quantification during chromatographic analysis. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory compliance teams involved in the development and manufacturing of Clofarabine-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Clofarabine API.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, or LC-MS methods to separate, identify, and quantify this specific impurity.
• Stability Studies: Used to monitor the formation and levels of this impurity in Clofarabine drug substance and products under various stress and storage conditions.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files and marketing applications.
• Pharmaceutical Research: Employed in research to understand the degradation pathways and impurity profile of Clofarabine during synthesis and formulation.
• Quality Assurance/Control (QA/QC): Serves as a system suitability and calibration standard in the batch release testing of Clofarabine to ensure compliance with pharmacopeial specifications (e.g., USP, EP).

Basic Information

Product Name	Clofarabine Impurity 14
CAS No.	1140251-36-0
Molecular Formula	C10H11ClFN5O3
Molecular Weight	303.68 g/mol
Synonyms	2-Chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)-9H-purin-6-amine Impurity 14; Clofarabine Related Compound 14; Clofarabine EP Impurity C; Clofarabine USP Impurity; (2R,3S,4R,5R)-2-(2-Chloro-6-aminopurin-9-yl)-5-(hydroxymethyl)-4-fluorooxolane-3,4-diol Impurity; 2-Amino-6-chloro-9-(2-deoxy-2-fluoro-β-D-arabinofuranosyl)purine Impurity; A potential isomer or degradation product of Clofarabine.
EINECS	Contact for details

Quality Control

Every batch of Clofarabine Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including purity (typically ≥95% by HPLC), is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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