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Pharmaceutical Chemicals

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Raloxifene Hydrochloride (Raloxifene HCL) Powder (82640-04-8)

 

Product name: Raloxifene hydrochloride
CAS : 82640-04-8
Molecular Formula: C28H28ClNO4S
Molecular Weight: 473.58328
Melting point: 143-147degree centigrade
Boiling Point: 728.2 degree centigrade at 760 mmHg
Flash Point: 394.2 degree centigrade
Density:1.285 g/cm3
Water solubility:DMSO: 28 mg/mL, soluble
Appearance: Light yellow solid
Indications: This product is mainly used to prevent postmenopausal osteoporosis
Usage of Raloxifene Hydrochloride : Used for the prevention and treatment of postmenopausal osteoporosis, can significantly reduce the incidence of vertebral fractures.

 

Raloxifene Hydrochloride Descriptions :

 

Raloxifene HCL is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of Raloxifene Hydrochloride , which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.

 

Raloxifene Hydrochloride Applications:

 

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 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.

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.

 

Raloxifene Hydrochloride 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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