Product name:Raloxifene hydrochloride
Alias: Raloxifene HCL;KEOXIFENE;AKOS 92138
CAS Registry Number:82640-04-8
Purity: 99%
MF: C28H28ClNO4S
MW: 510.04
Appearance:light yellow powder
Related Substances : Pharmaceutical Grade
Storage: Shading, confined preservation
Usage :It is used in the prevention of osteoporosis in postmenopausal women.
Description
| Product name | Raloxifene hydrochloride |
| Other name | Raloxifene HCL;KEOXIFENE;AKOS 92138 |
| CAS register number | 82640-04-8 |
| Molecular formula | C28H28ClNO4S |
| Molecular weight | 510.04 |
| Molecular structure |  |
| Melting point | 250-253°C |
| Assay | 99% |
Application
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 (e.g., bisphosphonates, calcitonin) or in whom such therapies are contraindicated.
Reduction in the incidence of invasive breast cancer in postmenopausal women with osteoporosis.
Reduction in the incidence of invasive breast cancer in postmenopausal 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.
Side effect: Raloxifene may infrequently cause serious blood clots to form in the legs, lungs, or eyes. Other reactions experienced include leg swelling/pain, trouble breathing, chest pain, vision changes. Raloxifene is a teratogenic drug, i.e., can cause developmental abnormalities such as birth defects.
Specification
| ITEMS | SPECIFICATION | RESULT | |
| Appearance | Light Yellow Powder | Conform | |
|
Solubility |
Soluble in 10% sodium hydroxide solution. Slightly Soluble in methanol. Insoluble in water |
Conform |
|
| Identifications | Infrared Absorption | Conform | |
| Chloride | Conform | ||
|
Tests
|
Loss on drying | ≤0.5% | 0.4% |
| Residue on ignition | ≤0.1% | 0.06% | |
| Heavy metals | ≤10ppm | Conform | |
|
RRelated substances
|
Raloxifene Impurity1 | ≤0.20 % | 0.10% |
|
Any unspecified individual impurity 2
|
≤0.10% | Max. 0.08% | |
| Total impurities | ≤0.50% | 0.40% | |
| Assay | Raloxifene HCl | ≥98.0% | 99.0% |
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