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|CAS Number:||25316-40-9||Appearance:||A Red-orange, Crystalline Powder|
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Antibiotics Cancer Treatment Drug Red Doxorubicin Hydrochloride Powder CAS 25316-40-9
Doxorubicin Hydrochloride is the hydrochloride salt of doxorubicin, an anthracycline antibiotic with antineoplastic activity. Doxorubicin, isolated from the bacterium Streptomyces peucetius var. caesius, is the hydroxylated congener of daunorubicin. Doxorubicin intercalates between base pairs in the DNA helix, thereby preventing DNA replication and ultimately inhibiting protein synthesis. Additionally, doxorubicin inhibits topoisomerase II which results in an increased and stabilized cleavable enzyme-DNA linked complex during DNA replication and subsequently prevents the ligation of the nucleotide strand after double-strand breakage. Doxorubicin also forms oxygen free radicals resulting in cytotoxicity secondary to lipid peroxidation of cell membrane lipids; the formation of oxygen free radicals also contributes to the toxicity of the anthracycline antibiotics, namely the cardiac and cutaneous vascular effects.
Product name: Doxorubicin hydrochloride
Usage: Topoisomerase II inhibitor. Antibiotic with cytotoxic actions.
Appearance: A red-orange, crystalline powder
Solubility. Soluble in DMSO to 25 mM and in water to 50 mM
Category: Cytotoxic drug
Storage: Store at -20°C. Store under desiccating conditions. The product can be stored for up to 12 months.
Items of analysis
|Appearance||evidence of contamination by foreign matter.||Conforms|
|Solubility||Soluble in water and methanol; slightly soluble in ethanol; practically insoluble in acetone.||Conforms|
|Identification A||IR spectrum corresponds to the IR spectrum of the reference standard||Conforms|
|Identification B||The retention time of the doxorubicin peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.||Conforms|
|pH||4.0 to 5.5||5.1|
|Water Content||Not More Than 4.0%||2.2%|
|Impurity A (Doxorubicinone)||Not More Than 0.5%||0.20%|
|Any Other unknown||Not More Than 0.2%||0.17%|
|Total unknown Impurities||Not More Than 1.0%||0.39%|
|Total Impurities||Not More Than 1.0%||0.59%|
|Assay||98.0% to 102.0% of C27H30ClNO11||99.1%|
|Acetone||Not More Than 0.5%||0.32%|
|Acetone +Ethanol||Not More Than 2.5%||0.62%|
|methanol||Not More Than 0.3%||Not detected|
|Dichloromethane||Not More Than 0.06%||Not detected|
Conventional doxorubicin: Treatment (in combination with other antineoplastic agents) of breast cancer.
AIDS-related Kaposi’s Sarcoma
Conventional doxorubicin: Has been used alone or in combination chemotherapy for the palliative treatment of AIDS-related Kaposi’s sarcoma.
Palliative treatment of AIDS-related Kaposi’s sarcoma in adults intolerant to combination chemotherapy or whose disease has progressed while receiving such therapy.
Conventional doxorubicin: Has been used in treatment (in combination chemotherapy regimens) of ovarian carcinoma, but other agents currently are preferred.
Palliative treatment of metastatic ovarian carcinoma that is refractory to both paclitaxel- and platinum-based chemotherapy regimens (designated an orphan drug by FDA for this use)
Conventional doxorubicin: Treatment (in combination regimens with cisplatin, methotrexate, and vinblastine) of invasive and advanced bladder carcinoma.
Has been used intravesically for treatment of residual tumor and/or as adjuvant therapy for prophylaxis of superficial bladder carcinoma.
Evidence is limited, but other agents (e.g. mitomycin, epirubicin) appear to be similar in efficacy but less toxic than doxorubicin and generally are preferred for prophylaxis or treatment of superficial bladder cancer.
Small Cell Lung Cancer
Conventional doxorubicin: Treatment (in combination chemotherapy regimens) of extensive-stage small cell lung cancer.
Conventional doxorubicin hydrochloride: Treatment of solid tumors including thyroid carcinoma, gastric carcinoma, soft-tissue and osteogenic sarcomas, neuroblastoma, and Wilms' tumor; malignant lymphomas of both Hodgkin and non-Hodgkin type; and acute lymphocytic (lymphoblastic) leukemia.
Conventional doxorubicin hydrochloride: Treatment of carcinoid tumors, hepatoblastoma†, and retinoblastoma.
Conventional doxorubicin hydrochloride: Treatment of Ewing’s sarcoma, squamous cell carcinoma of the cervix and prostate, and uterine cancer.
Conventional doxorubicin hydrochloride: Used in combination therapy (with vincristine and high-dose dexamethasone) for refractory multiple myeloma.
Although conventional doxorubicin is labeled for use in the treatment of AML,200 208 other agents are preferred.
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