Description

Doxorubicin Impurity B is a specified impurity of the potent anthracycline chemotherapeutic agent, Doxorubicin. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Doxorubicin drug substances and products. It is primarily utilized by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Doxorubicin Impurity B in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Doxorubicin formulations.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Doxorubicin.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with the FDA, EMA) to establish impurity limits and justify specifications.
• Research and Development: Supports impurity profiling and structural elucidation studies during the synthesis and process development of Doxorubicin and its analogs.

Basic Information

Product Name	Doxorubicin Impurity B
CAS No.	106401-68-7
Molecular Formula	C27H29NO10
Molecular Weight	527.52 g/mol
Synonyms	7-Deoxydoxorubicinone; 7-Deoxy-13-dihydrodoxorubicinone; Doxorubicin EP Impurity B; Doxorubicin Related Compound B; Adriamycin Impurity B; (7S,9S)-7-((2R,4S,5S,6S)-4-Amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione
EINECS	Contact for details

Quality Control

Our Doxorubicin Impurity B is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity determination and spectroscopic methods (NMR, MS) for structural confirmation, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and light-sensitive. Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent moisture absorption.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
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.