Description

Doxorubicin Impurity 14 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, quality control, and regulatory compliance. It is primarily needed by pharmaceutical manufacturers, analytical testing laboratories, and research institutions focused on ensuring the purity, safety, and efficacy of doxorubicin-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material for the identification and quantification of impurities in Doxorubicin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in doxorubicin formulations under various storage conditions.
• Research on Degradation Pathways: Used in academic and industrial research to study the chemical stability and degradation mechanisms of anthracycline drugs.

Basic Information

Item	Detail
Product Name	Doxorubicin Impurity 14
CAS No.	105612-58-6
Molecular Formula	C₂₇H₂₉NO₁₀
Molecular Weight	527.52 g/mol
Synonyms	10-Deacetyl-10-(3-hydroxypropyl)doxorubicin; 10-Deacetyl-10-(3-hydroxypropyl)adriamycin; Doxorubicin EP Impurity H; Doxorubicin Related Compound H; Adriamycin Impurity 14; (8S,10S)-10-[3-Hydroxypropyl]-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione; 10-Deacetyl-10-(3-hydroxypropyl)doxorubicinone
EINECS	Contact for details

Quality Control

Our Doxorubicin Impurity 14 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural verification by spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic and spectroscopic data are provided 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. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive); desiccants are recommended for long-term storage.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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