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Product name: Raloxifene Hydrochloride
CAS No: 82640-04-8
MF: C28H28ClNO4S
MW: 510.04
Purity: 99%min.
Appearance: Faint yellow powder
Usage : Raloxifene is a selective estrogen receptor modulator (SERM); acts as an anti-estrogen in both breast and uterine tissue while being estrogenic in bone. May have efficacy against estrogen-sensitive cancers.
Description:
Raloxifene (marketed as Evista) is an oral selective estrogen receptor modulator (SERM) that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast. It is used in the prevention of osteoporosis in postmenopausal women and to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
This drug is different from hormones (including estrogens and progestins). It works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. Raloxifene helps to preserve bone mass, but it does not affect the breast and uterus like estrogen or relieve symptoms of menopause such as hot flashes.
Evista (Raloxifene Hydrochloride) is an estrogen agonist/antagonist, referred to as a selective estrogen receptor modulator (SERM) and belongs to the benzothiophene class of compounds. The biological actions of Raloxifene are largely mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (Agonism) and and the blockade of estrogenic pathways in other tissues (Antagonism).
Application:
Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. It is also used for reduction of risk and treatment of invasive breast cancer, and it also reduces breast density.For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Raloxifene is used to prevent and treat bone loss (osteoporosis) in women after menopause. Maintaining strong bones by slowing bone loss helps to reduce the risk of fractures.
Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive) in women after menopause.
May prevent or treat corticosteroid-induced bone loss. American College of Rheumatology states that raloxifene can be offered to selected postmenopausal corticosteroid-treated women who refuse hormone replacement therapy or other antiresorptive agents or in whom such therapies are contraindicated.
Reduction in the incidence of invasive breast cancer inpostmenopausal women at high risk for developing the disease. Effect comparable to that of tamoxifen in reducing the risk of invasive breast cancer (STAR trial). No effect on the risk of lobular carcinoma in situ or ductal carcinoma in situ (STAR trial).
Effect on breast cancer incidence in women with BRCA1 or BRCA2 genetic mutations not established. Not indicated for the treatment of breast cancer or to reduce the risk of recurrence of breast cancer. 1 Not indicated for reduction in the risk of noninvasive breast cancer.
COA:
|
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 |
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