Doxorubicin Hydrochloride is an anthracycline antineoplastic active pharmaceutical ingredient (API) used in the manufacture of pharmaceutical formulations for cancer treatment. It is a hydrochloride salt of doxorubicin and belongs to the anthracycline class of antineoplastic agents.
Doxorubicin Hydrochloride is a cytotoxic anthracycline antibiotic with antineoplastic activity. It acts through several mechanisms, including interaction with DNA, inhibition of topoisomerase II, and generation of free radicals.
Doxorubicin Hydrochloride is supplied as a pharmaceutical active ingredient for use in the development and manufacture of oncology formulations. The API is characterized by its anthracycline structure and is commonly used in injectable pharmaceutical products.
Doxorubicin interacts with DNA through intercalation and inhibits topoisomerase II, interfering with DNA replication and transcription. Its pharmacological activity also involves free-radical formation and cellular damage.
Doxorubicin Hydrochloride is used in pharmaceutical formulations for the treatment of various malignant diseases, including certain:
The specific indication depends on the approved formulation and regulatory labeling.
Doxorubicin Hydrochloride is a red to orange crystalline powder or granular material. Its molecular formula is C₂₇H₂₉NO₁₁·HCl and molecular weight is 579.98 g/mol.
Doxorubicin Hydrochloride API should be manufactured, tested and released according to applicable pharmaceutical quality standards. Analytical testing may include identification, assay, related substances, water content, residual solvents and other applicable quality attributes.
Doxorubicin Hydrochloride is an important oncology API used in pharmaceutical manufacturing. Buyers and formulation manufacturers can evaluate the material based on applicable pharmacopoeial standards, Certificate of Analysis, regulatory documentation and batch-specific quality requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Doxorubicin Hydrochloride identification tests |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 216°C (decomposes) |