Description

Cytarabine Impurity 10 CAS NO 84902-98-7 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of the chemotherapeutic agent Cytarabine by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and manufacturing, particularly for oncology drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Cytarabine Impurity 10 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles in Cytarabine batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Cytarabine API and drug formulations meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Cytarabine.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Facilitates process chemistry research aimed at minimizing or eliminating this specific impurity during the synthesis and purification of Cytarabine.

Basic Information

Product Name	Cytarabine Impurity 10
CAS No.	84902-98-7
Molecular Formula	C9H13N3O5
Molecular Weight	243.22 g/mol
Synonyms	1-β-D-Arabinofuranosyl-2(1H)-pyrimidinone; 1-β-D-Arabinofuranosyl-2-pyrimidinone; 1-(β-D-Arabinofuranosyl)-2(1H)-pyrimidinone; Cytosine Arabinoside Impurity 10; Ara-C Impurity 10; 2(1H)-Pyrimidinone, 1-β-D-arabinofuranosyl-; 1-(β-D-Arabinofuranosyl)pyrimidin-2(1H)-one
EINECS	Contact for details

Quality Control

Our Cytarabine Impurity 10 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and tested using advanced analytical techniques including HPLC, NMR, and MS to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, impurity profile, and analytical results. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines for impurities in new drug substances.

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. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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