Description

Doxorubicin Impurity 6 is a specified impurity and degradation product of the critical anticancer agent doxorubicin. This compound is essential for pharmaceutical research and development, serving as a critical reference standard for analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on ensuring the purity, safety, and efficacy of doxorubicin-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in doxorubicin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability testing of doxorubicin formulations.
• Quality Control & Assurance: Integral for setting impurity specifications and ensuring batch-to-batch consistency of doxorubicin API in GMP manufacturing environments.
• Pharmacopeial Testing: Supports testing procedures aligned with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, MAA) with agencies like the FDA and EMA.

Basic Information

Product Name	Doxorubicin Impurity 6
CAS No.	69429-21-6
Molecular Formula	C27H29NO11
Molecular Weight	543.52 g/mol
Synonyms	Doxorubicin EP Impurity C; Doxorubicin Related Compound C; 7-Deoxydoxorubicinone; 7-Deoxydoxorubicin aglycone; Adriamycin Impurity C; (7S,9S)-7-((2R,4S,5S,6S)-4-Amino-5-hydroxy-6-methyloxan-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

Every batch of Doxorubicin Impurity 6 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity and related substance data.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a controlled environment to prevent degradation.

Specification

Item	Specification
Appearance	Orange to red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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