Bazedoxifene Acetate is a selective estrogen receptor modulator (SERM) used as an active pharmaceutical ingredient in formulations for the management of postmenopausal conditions. Bazedoxifene selectively interacts with estrogen receptors and produces tissue-specific estrogen agonist or antagonist effects.
Bazedoxifene is used in pharmaceutical products for the treatment of postmenopausal osteoporosis and, in combination with conjugated estrogens, for the treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis.
Bazedoxifene Acetate is used in pharmaceutical formulations for:
Bazedoxifene is a selective estrogen receptor modulator. It binds to estrogen receptors and produces different effects depending on the target tissue. Its estrogen-antagonistic activity in breast and uterine tissues and estrogen-like activity in bone contribute to its therapeutic applications.
Bazedoxifene Acetate API should be manufactured and tested according to applicable pharmaceutical quality standards and the approved product specification. Quality controls may include identity, assay, related substances, residual solvents, water content, elemental impurities and other applicable analytical parameters.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to identification tests for Bazedoxifene Acetate |
| Assay (HPLC) | As per applicable pharmacopoeial/approved product specification |
| Loss on Drying | As per approved specification |
| Heavy Metals | Complies with applicable elemental impurity requirements |
| Specific Rotation | As per approved stereochemical specification |
| Solubility | Slightly soluble in water; soluble in organic solvents such as methan |