Description

Doxorubicin Impurity 15 is a structurally defined chemical impurity associated with the widely used anthracycline chemotherapeutic agent, Doxorubicin. This compound is of critical importance for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Doxorubicin API and its formulated 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 & Validation: Essential for developing, optimizing, and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for establishing specification limits and ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products in Doxorubicin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Doxorubicin to minimize impurity formation.

Basic Information

Product Name	Doxorubicin Impurity 15
CAS No.	131086-18-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Doxorubicin Related Compound 15; Doxorubicin EP Impurity J; Doxorubicin USP Related Compound; 7-Deoxy-13-dihydrodoxorubicinone; Adriamycin Impurity 15; Doxorubicin Degradant; (7S,9S)-7-Deoxy-9-hydroxy-10-[(2S,4S,5S,6S)-4-hydroxy-5-methoxy-6-methyloxan-2-yl]oxy-6,8,11-trihydroxy-7,8,9,10-tetrahydrotetracene-5,12-dione
EINECS	Contact for details

Quality Control

Every batch of Doxorubicin Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, NMR, MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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