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Assay: 99% by HPLC
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Raloxifene hydrochlorideis an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale yellow solid that is very slightly soluble in water.
EVISTA (raloxifene) is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 g of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrouslactose, 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.
|Appearance||White &off-white powder||Conform|
|Solubility||Soluble in 10% sodium hydroxide solution. Slightly Soluble in methanol. Insoluble in water||Conform|
|Tests||Loss on drying||≤0.5%||0.4%|
|Residue on ignition||≤0.1%||0.06%|
|Related substances||≤0.20 %||0.10%|
|Any unspecified individual impurity 2||≤0.10%||Max. 0.08%|
1) May prevent or treat corticosteroid-induced bone loss. American College of Rheumatology states that raloxifene can be offered to select postmenopausal corticosteroid-treated women who refuse hormone replacement therapy or other antiresorptive agents (e. G., bisphosphonates, calcitonin) or in whom such therapies are contraindicated.
2) Reduction in the incidence of invasive breast cancer in postmenopausal women with osteoporosis.
3) Reduction in the incidence of invasive breast cancer 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.
Chemical Properties: Light-Yellow Solid
Usage: amino acid, nutrient, A nonsteroidal, selective estrogen receptor modulator (SERM). Antiosteoporotic.