Description

Doxorubicin Impurity 18 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used anthracycline chemotherapeutic agent, doxorubicin. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in doxorubicin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for doxorubicin analysis to meet ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of doxorubicin.
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of doxorubicin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Research & Development: Facilitates research into the metabolism, degradation pathways, and structure-activity relationships of doxorubicin and related compounds.

Basic Information

Item	Details
Product Name	Doxorubicin Impurity 18
CAS No.	59325-97-2
Molecular Formula	C₂₇H₂₉NO₁₀
Molecular Weight	527.52 g/mol
Synonyms	Doxorubicinone, 7-Deoxy-13-dihydro-; 7-Deoxy-13-dihydrodoxorubicinone; 7-Deoxy-13-dihydrodoxorubicin aglycone; Doxorubicin EP Impurity D; Doxorubicin Related Compound D; Adriamycin Impurity D; (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 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic confirmation 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.