Description

Epirubicin Ep Impurity F is a specified impurity of the anthracycline chemotherapeutic agent Epirubicin, identified by the CAS registry number 57918-24-8. This compound is of critical importance in the pharmaceutical industry for analytical research and quality control, ensuring the purity and safety of the active pharmaceutical ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Epirubicin HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Used in developing and validating high-performance liquid chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC labs to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of degradation products in Epirubicin formulations under various stress conditions.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical stability of Epirubicin.

Basic Information

Product Name	Epirubicin Ep Impurity F
CAS No.	57918-24-8
Molecular Formula	C27H29NO11
Molecular Weight	543.52 g/mol
Synonyms	4'-Epiadriamycinone; 4'-Epidoxorubicinone; 7-Deoxy-13-dihydrodaunorubicin; 4'-Epidoxorubicin Impurity F; Epirubicin Related Compound F; 4'-Epiadriamycin; (8S,10S)-8-Acetyl-10-[(2S,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,8,11-trihydroxy-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione
EINECS	Contact for details

Quality Control

Our Epirubicin Ep Impurity F is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept sealed in a desiccated environment and away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (by HPLC)	≥ 95.0%
Related Substances (by 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.