Description

Zidovudine Related Compound B (3'-Chloro-3'-Deoxythymidine) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound serves as a critical impurity standard for the antiretroviral drug Zidovudine (AZT), ensuring the accuracy and reliability of analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development, stability studies, and regulatory compliance testing. The 25 mg quantity is ideal for precise laboratory-scale applications.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specified impurities in Zidovudine (AZT) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of related substances in Zidovudine formulations under various storage conditions.
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing essential data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research and Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways and stability of nucleoside reverse transcriptase inhibitors.
• Quality Assurance/Quality Control (QA/QC): An integral component of in-house quality testing protocols to ensure batch-to-batch consistency and purity of Zidovudine.

Basic Information

Product Name	Zidovudine Related Compound B (3'-Chloro-3'-Deoxythymidine)
CAS No.	25526-94-7
Molecular Formula	C10H13ClN2O5
Molecular Weight	276.67 g/mol
Synonyms	3'-Chloro-3'-deoxythymidine; 1-[(2R,4S,5S)-4-Chloro-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione; AZT Related Compound B; Zidovudine Impurity B; 3'-Chloro-2',3'-dideoxythymidine; CL-ddT; 3'-Chloro-3'-deoxy-5-methyluridine; 3'-Chloro-3'-deoxythymidine (Zidovudine Related Substance B)
EINECS	Contact for details

Quality Control

Every batch of Zidovudine Related Compound B is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided to guarantee traceability and support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed tightly after each use to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	White to off-white powder
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 impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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