Alias: Raloxifene Hydrochloride; KEOXIFENE
CAS: 82640-04-8
Purity: 99%
MF: C28H28ClNO4S
MW: 510.04
Appearance: Light yellow powder
Related Substances: Pharmaceutical Grade
Storage: Shading, confined preservation
Raloxifen hydrochloride, a second-generation Selective Estrogen Receptor Modulator (SERM) in the Raloxifene hydrochloride benzothiophene family. On September 13, 2007, the U. S. Food and Drug Administration approved Evista for reduction in the risk of invasive breast cancer in postmenopausal women with and Raloxifene hydrochloride without osteoporosis. It has also been approved as a potent stand-alone osteoporosis treatment.
Raloxifene is used to prevent and treat osteoporosis (condition in which the bones become thin and weak and break easily) in women have undergone menopause. Raloxifene is also used to decrease the risk of developing invasive breast cancer (breast cancer that has spread outside of the milk ducts or lobules into the surrounding breast tissue).
Raloxifene prevents and treats osteoporosis by mimicking the effects of estrogen (a female hormone produced by the body) to increase the density (thickness) of bone. Raloxifene decreases the risk of developing invasive breast cancer by blocking the effects of estrogen on breast tissue. This may stop the development of tumors that need estrogen to grow.
Test items |
Specification |
Test results |
Appearance |
Yellowish powder |
Comply |
Identification |
Ir |
Comply |
|
It meets the requirements of the test for choride |
Comply |
Solubility |
Soluble in 10% sodium hydroxide solution,
slightly soluble in methanol,insoluble in water |
Comply |
Assay |
98.5%~101.5% |
99.15% |
Related substances |
Rrt=0.74 impurity |
≤0.20% |
Comply |
|
Other single impurity |
≤0.10% |
0.07% |
|
Total impurities |
≤0.5% |
0.26% |
Loss on drying |
≤0.5% |
0.10% |
Residue on ignition |
≤0.1% |
Comply |
Heavy metals |
≤10ppm |
Comply |
Storage |
Preserve in well-closed containers and protected from light.Store at room temperature. |
Conclusion |
Complies with usp32 standard |