Description

7,8-Desacetyl-9,10-Dehydro Daunorubicinone (Doxorubicin Impurity) is a key chemical reference standard and impurity used in the development and quality control of anthracycline-based pharmaceuticals. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) like doxorubicin, a vital chemotherapeutic agent. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in method validation, stability studies, and regulatory compliance. The CAS number for this compound is 1159977-24-8.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of related substances in doxorubicin API and finished drug products.
• Impurity Profiling & Characterization: Essential for conducting forced degradation studies and establishing impurity profiles to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development & Validation: Used as a system suitability and calibration standard in HPLC, LC-MS, and other chromatographic methods.
• Process Chemistry Research: Employed in studying the synthesis pathways and degradation mechanisms of anthracycline drugs to optimize manufacturing processes.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity identification and control strategies.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing to monitor impurity levels and ensure product consistency.

Basic Information

Product Name	7,8-Desacetyl-9,10-Dehydro Daunorubicinone (Doxorubicin Impurity)
CAS No.	1159977-24-8
Molecular Formula	C19H14O7
Molecular Weight	354.31 g/mol
Synonyms	9,10-Dehydro-7,8-dideacetyldaunorubicinone; 7-Deacetyl-9,10-dehydrodaunorubicinone; Doxorubicin Impurity; Daunorubicinone, 7,8-didesacetyl-9,10-dehydro-; Anthracycline Impurity; 7,8-Didesacetyl-9,10-dehydrodaunorubicinone
EINECS	Contact for details

Quality Control

Every batch of 7,8-Desacetyl-9,10-Dehydro Daunorubicinone is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity profiles as determined by advanced analytical techniques.

Storage

Preserve in a tightly closed container, protected from light. Store under an inert atmosphere (e.g., nitrogen or argon) at a controlled room temperature (15-25°C) to minimize oxidation and ensure long-term stability. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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