Product Name: Doxorubicin hydrochloride
CAS: 25316-40-9
MF: C27H30ClNO11
MW: 579.98
EINECS: 246-818-3
Liquescens punctum: 216 °C (dec.)(lit.)
Repono temp.: 2-8°C
Doxorubicin is available as both the conventional dosageform and a liposomal preparation, both of which are administeredby infusion. Doxorubicin HCl powder is available in10-, 20-, 50-, and 150-mg vials and is widely used in treatingvarious cancers, including leukemias, soft and bone tissuesarcomas, Wilms tumor, neuroblastoma, small cell lungcancer, and ovarian and testicular cancer.
Doxorubicin is an anthracycline antitumor antibiotic that inhibits DNA topoisomerase II by inducing double-stranded DNA breaks. By intercalating within DNA, doxorubicin inhibits nucleic acid synthesis and induces apoptosis by inducing the accumulation of the p53 tumor suppressor protein.
It is commonly used in the treatment of a wide range of cancers, including hematological malignancies (blood cancers, like leukaemia and lymphoma), many types of carcinoma (solid tumours) and soft tissue sarcomas.It is often used in combination chemotherapy as a component of various chemotherapy regimens.
| Items Tested |
Specification |
Proventus |
| Puritas |
98.0~102.0% |
99.02% |
| Descriptio |
Orange-red or red crystalline powder; No visible
evidence of contamination by foreign matter. |
Confirm |
| Identification A |
IR spectrum corresponds to the IR spectrum of the reference standard |
Confirm |
| 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. |
Confirm |
| Solubilitas |
Soluble in water and methanol; slightly soluble in ethanol; practically insoluble in acetone. |
Conforms |
| Residual Solvents |
|
|
| Acetone |
≤ 0.5% |
0.31% |
| Acetone +Ethanol |
≤ 2.5% |
0.60% |
| methanol |
≤ 0.3% |
Not detected |
| Dichloromethane |
≤ 0.06% |
Not detected |
| pH* |
4.0 to 5.5 |
5.1 |
| Aqua Content |
≤ 4.0% |
0.8% |
| Related Substances |
|
|
| Impurity A (Doxorubicinone) |
≤ 0.5% |
0.1% |
| Any Other unknown Impurity |
≤ 0.1% |
0.07% |
| Total unknown Impurities |
≤ 0.3% |
0.2% |
| Total Impurities |
≤ 1.0% |
0.9% |
| conclusio |
It complies to reference standard |
