Description

Cytarabine Impurity 1 is a specified impurity of the critical antineoplastic agent Cytarabine, used in pharmaceutical quality control and analytical research. This compound is essential for the development and validation of analytical methods to ensure the purity, safety, and efficacy of the parent drug substance. It serves as a critical reference standard for researchers and quality assurance professionals in the pharmaceutical and biotechnology industries, particularly those involved in oncology drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Cytarabine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in Cytarabine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthetic process of Cytarabine.

Basic Information

Product Name	Cytarabine Impurity 1
CAS No.	4348-60-1
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosyluracil; 1-β-D-Arabinofuranosyl-2-pyrimidinone; Ara-U; Uracil-1-β-D-arabinofuranoside; 1-(β-D-Arabinofuranosyl)uracil; Cytarabine Related Compound A; Uridine, 2'-deoxy- (VAN); 2'-Deoxyuridine (ambiguous, verify structure)
EINECS	Contact for details

Quality Control

Every batch of Cytarabine Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and MS to ensure they meet the exacting standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 must be kept under dry, inert conditions to maintain stability and purity. 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)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5%; Total impurities ≤ 2.0%

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