Epirubicin is an anthracycline anticancer drug used as part of chemotherapy, particularly in the treatment of breast cancer. It is commonly supplied in its hydrochloride form, Epirubicin Hydrochloride, and belongs to the anthracycline class of cytotoxic agents. Epirubicin works primarily by inhibiting topoisomerase II and interfering with DNA replication and repair, resulting in inhibition of cancer cell growth.
Epirubicin Hydrochloride is a semi-synthetic derivative of daunorubicin and is the 4-epimer of doxorubicin. It is a red-orange hygroscopic powder in its active pharmaceutical ingredient form. The molecular formula of epirubicin hydrochloride is C₂₇H₂₉NO₁₁·HCl, with a molecular weight of approximately 579.95 g/mol.
Epirubicin is primarily used as an anticancer medicine in combination chemotherapy. Approved labeling includes its use as a component of adjuvant therapy for patients with axillary lymph node involvement following resection of primary breast cancer.
Epirubicin exerts its antineoplastic activity through interaction with DNA and inhibition of topoisomerase II, an enzyme required for DNA replication and repair. This mechanism results in DNA damage and contributes to the inhibition of rapidly dividing cancer cells.
Epirubicin Hydrochloride is an important pharmaceutical ingredient used in the development and manufacture of oncology formulations. It is generally administered by the intravenous route under the supervision of healthcare professionals experienced in cytotoxic chemotherapy.
Epirubicin Hydrochloride intended for pharmaceutical manufacturing should be produced and tested according to applicable pharmaceutical quality standards and the manufacturer's approved specification. Critical quality attributes may include identity, assay, related substances, water content, residual solvents, elemental impurities, microbial quality where applicable, and other product-specific tests.
Epirubicin Hydrochloride injection products are generally stored under controlled refrigerated conditions and protected from light. Exact storage requirements should follow the applicable approved product specification and manufacturer's documentation.
A reliable Epirubicin API supplier should provide consistent quality, appropriate analytical documentation, batch traceability, and regulatory support for pharmaceutical manufacturing requirements. Product specifications, certificates of analysis, and regulatory documentation should be reviewed according to the intended application and market.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 4.0 – 5.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 3.0% |
| Water Content | NMT 4.5% |
| Melting Point | Approximately 185°C |