Description

Epirubicin Hydrochloride is a semi-synthetic anthracycline antibiotic and a key chemotherapeutic agent. It is valued for its efficacy in treating various cancers, offering a critical therapeutic option in oncology. This product is essential for pharmaceutical manufacturers, research institutions, and compounding facilities developing injectable anti-cancer formulations.

Application

• Oncological Pharmaceutical Manufacturing: Primary active pharmaceutical ingredient (API) in injectable chemotherapy drugs.
• Breast Cancer Treatment: A cornerstone in adjuvant and neoadjuvant therapy regimens for early-stage and advanced breast cancer.
• Gastric Cancer Therapy: Used in combination chemotherapy protocols for advanced gastric adenocarcinoma.
• Ovarian Cancer Treatment: Component of platinum-based combination therapies.
• Small Cell Lung Cancer (SCLC) Management: Part of first-line treatment combinations.
• Biomedical Research: Used in preclinical studies to investigate cancer mechanisms, drug resistance, and novel combination therapies.
• Drug Delivery System Development: A model compound for researching liposomal, nanoparticle, and other targeted delivery platforms to improve therapeutic index.

Basic Information

Product Name	Epirubicin Hydrochloride
CAS No.	56390-09-1
Molecular Formula	C₂₇H₂₉NO₁₁ • HCl
Molecular Weight	579.98 g/mol
Synonyms	4'-Epidoxorubicin Hydrochloride; Pidorubicin Hydrochloride; IMI-28; NSC 256942; Farmorubicin; (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride
EINECS	Contact for details

Quality Control

Our Epirubicin Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing all test results, including assay, related substances, and residual solvents, is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C or under refrigeration at 2-8°C as specified. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	Orange-red powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 3.0%
Residual Solvents (GC)	Complies with ICH guidelines
Specific Rotation	+220° to +240° (c=1 in H₂O)
Bacterial Endotoxins	< 1.0 EU/mg

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