Quick detail
Name: Raloxifene
CAS No.: 84449-90-1
Formula: C28H27NO4S
Molecular Weight: 473.58
Synonyms: Keoxifene;LY 139481;[2-(4-Hydroxyphenyl)-6-hydroxybenzo[b]thien-3-yl][4-(2-(1-piperidinyl)ethoxy)phenyl]methanone;
Density: 1.289 g/cm3
Melting Point: 250-253 °C
Boiling Point: 728.2 °C at 760 mmHg
Flash Point: 394.2 °C
Solubility: DMSO: 28 mg/mL, soluble
Appearance: light-yellow solid
Product Categories: Raloxifene;Intermediates & Fine Chemicals;Pharmaceuticals;Pharmaceutical intermediate
Usage : A nonsteroidal estrogen receptor mixed agonist/antagonist
Raloxifene Description
Raloxifene, a member of the class of selective estrogen receptor modulators (SERM), reproduces the beneficial effects of estrogens on the skeletal systems, without the negative effects estrogens on breast and endometrium.
This is a review article summarizing its mechanism, effects on bone and its applicability in traumatology clinical practice. In postmenopausal osteoporosis, this drug has been proven to decrease accelerated bone turnover, increase bone mineral density (BMD), and to structurally recover bone, decreasing the risk of vertebral fractures and the risk of non-vertebral fractures in patients with previous, severe vertebral fractures.
Moreover, raloxifene appears to lower the risk of invasive breast cancer. Raloxifene would be efficacious in the prevention and treatment of postmenopausal osteoporosis.
We can therefore conclude that raloxifene would be efficacious in the prevention and treatment of postmenopausal osteoporosis, while reducing the risk of breast cancer when used at the indicated dose of 60 mg/day and with a low incidence of side effects.
Before taking raloxifene,
tell your doctor and pharmacist if you are allergic to raloxifene or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), cholestyramine (Questran), colestipol (Colestid), diazepam (Valium), diazoxide (Proglycem), medications that contain estrogen such as hormone replacement therapy (ERT or HRT), and lidocaine (Lidoderm, Xylocaine).
tell your doctor if you have any type of cancer and if you have or have ever had breast lumps or breast cancer; heart failure; kidney disease; or liver disease. If you have ever taken estrogen, tell your doctor if your triglycerides increased during your treatment.
you should not use raloxifene unless you have already undergone menopause and cannot become pregnant. However, tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
you should know that raloxifene has not been found to cause spotting or menstrual-like bleeding nor to increase the risk of cancer of the lining of the uterus. Tell your doctor if you develop vaginal bleeding or spotting. Your doctor will need to examine you or order tests to find the cause of the bleeding.
you should know that although raloxifene decreases the chance that you will develop invasive breast cancer, there is still a risk that you will develop this condition. You will still need regularly scheduled breast exams and mammograms before you start taking raloxifene and during your treatment with raloxifene. Call your doctor if you notice tenderness, enlargement, lumps, or any other changes in your breasts.
if you are taking raloxifene to treat osteoporosis, talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
Certificate of Analysis
ITEMS | SPECIFICATION | RESULT |
Appearance | White &off-white powder | Conforms |
Grade | Anti Estrogen Steroids | Conforms |
Solubility | Soluble in 10% sodium hydroxide solution. Slightly Soluble in methanol. Insoluble in water | Conforms |
Identifications | Infrared Absorption | Conforms |
Loss on drying | ≤0.5% | 0.4% |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤10ppm | Conforms |
Raloxifene Impurity1 | ≤0.20 % | 0.10% |
Any unspecified individual impurity 2 | ≤0.10% | Max. 0.08% |
Total impurities | ≤0.50% | 0.40% |
Raloxifene | ≥98.0% | 99.0% |