Description

Epirubicin is a semi-synthetic anthracycline antibiotic and a key chemotherapeutic agent derived from daunorubicin. Its primary value lies in its potent antineoplastic activity, which is critical for inhibiting the growth of rapidly dividing cancer cells. This compound is essential for pharmaceutical manufacturers and research institutions developing treatments for various carcinomas, including breast, gastric, and ovarian cancers. Epirubicin CAS NO 32469-41-3 represents a high-purity active pharmaceutical ingredient (API) for the formulation of injectable oncology drugs.

Application

• Oncological Drug Formulation: Primary use as the active pharmaceutical ingredient (API) in injectable chemotherapy solutions for clinical treatment.
• Breast Cancer Therapy: A cornerstone agent in adjuvant and neoadjuvant chemotherapy regimens for early-stage and advanced breast cancer.
• Gastric Cancer Treatment: Used in combination therapy protocols for advanced gastric adenocarcinoma.
• Ovarian Cancer Management: Incorporated into chemotherapeutic cocktails for epithelial ovarian cancer.
• Bladder Cancer Therapy: Applied in intravesical instillation for superficial bladder cancer.
• Pharmaceutical Research & Development: Serves as a reference standard and a starting material for the synthesis of novel anthracycline derivatives and drug conjugates.
• Mechanistic Studies: Used in biochemical and pharmacological research to study topoisomerase II inhibition, DNA intercalation, and free radical generation.

Basic Information

Product Name	Epirubicin
CAS No.	32469-41-3
Molecular Formula	C27H29NO11
Molecular Weight	543.52 g/mol
Synonyms	4'-Epidoxorubicin; 4'-Epiadriamycin; IMI-28; Pharmorubicin; Ellence; Epirubicin Hydrochloride; (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione
EINECS	251-063-6

Quality Control

Our Epirubicin is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling against relevant pharmacopeial standards (e.g., USP, EP). A Certificate of Analysis (COA) detailing all test results is provided to guarantee traceability and compliance for regulatory submissions and GMP manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), or as specified on the label. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	Orange-red powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 5.0 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

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