Description

Cytarabine Impurity 10 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 industry, particularly those involved in oncology drug manufacturing and regulatory compliance.

Application

• As a pharmaceutical reference standard for the identification and quantification of Cytarabine Impurity 10 in active pharmaceutical ingredients (APIs) and finished drug products.
• For use in analytical method development and validation (e.g., HPLC, UPLC, GC) to meet ICH Q2(R1) and other regulatory guidelines.
• Critical component in stability studies and impurity profiling to monitor degradation pathways of Cytarabine.
• Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity material for submission to agencies like the US FDA and EMA.
• Used in quality control laboratories for routine batch release testing of Cytarabine API to ensure it meets pharmacopeial specifications (e.g., USP, EP).
• Essential for research and development of synthetic routes and purification processes to minimize this specific impurity.

Basic Information

Item	Detail
Product Name	Cytarabine Impurity 10
CAS No.	32830-01-6
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosylcytosine N-Oxide; Ara-C N-Oxide; Cytarabine N-Oxide; 1-(β-D-Arabinofuranosyl)-2(1H)-pyrimidinone; Cytosine arabinoside N-oxide; 2(1H)-Pyrimidinone, 1-β-D-arabinofuranosyl-
EINECS	Contact for details

Quality Control

Our Cytarabine Impurity 10 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance in regulated environments.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.