Anastrozole is an aromatase-inhibiting drug approved for treatment of breast cancer after surgery, as well as for
metastasis in both pre and postmenopausal women. The severity of breast cancer is increased by estrogen, as sexhormones cause hyperplasia, and differentiation at estrogen receptor sites. Anastrozole works by inhibiting the synthesis of estrogen.
The trial suggested that anastrozole is the preferred medical therapy for Postmenopausal women with localized breast cancer that is estrogen receptor (ER) positive.
Three azole potent selective aromatase inhibitors, which inhibit rely on aromatase cytochrome P -450 to block
estrogen biosynthesis, and the main factors of estrogen to stimulate breast cancer cell growth. It can treat breast cancer, especially suitable for those who relapse after treatment with hormone auxiliary advanced breast cancer after menopause women.
Below is the test results of Anastrozole:
Items | Standard | Results |
Description | White crystalline powder | Complies |
Identification | IR | Conform with standard IR |
Solubility | Freely soluble in methanol, acetone, ethanol and tetrahydrofuran. And very soluble in acetonitrile | Complies |
Total Impurity | max.0.5% | 0.18% |
Total Unspecified Impurity | max. 0.2% | 0.08% |
Individual unspecified impurlty | max. 0.1% | 0.05% |
Related compound B | max. 0.2% | 0.07% |
Related compound C | max. 0.2% | 0.04% |
Related compound D | max. 0.1% | 0.05% |
Related compound E | max. 0.1% | 0.06% |
Limit of cyclohexane | max. 0.08% | ND |
Limit of ethylacetate | max. 0.1% | 0.07% |
Melting point | 81.0~84.0 | 82.5～83.2 |
Water | max. 0.3% | 0.21% |
Residue on ignition | max. 0.1% | 0.07% |
Heavy Metals | max.0.001% | Complies |
Assay(HPLC) | 98.0%～102.0% | 99.8% |
Storage | Cool and dry |
