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Raloxifene Hydrochloride is a selective estrogen receptor modulator (SERM) primarily used for the prevention and treatment of osteoporosis in postmenopausal women and for reducing the risk of invasive breast cancer in high-risk patients. It acts by mimicking estrogen’s beneficial effects on bone while blocking estrogenic activity in breast and uterine tissues, offering targeted therapeutic benefits.
Bluepill Express manufactures high-purity Raloxifene HCl API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with IP, BP, USP, and EP standards. This API is suitable for oral tablet formulations and combination therapies, catering to domestic and international pharmaceutical markets.
Therapeutic Uses
- Osteoporosis Prevention & Treatment: Increases bone mineral density in postmenopausal women
- Breast Cancer Risk Reduction: Lowers risk of invasive breast cancer in high-risk patients
- Hormone Replacement Therapy Alternative: Provides estrogen-like benefits without stimulating breast or uterine tissue
- Combination Therapy: Can be used alongside calcium and vitamin D supplementation
- Postmenopausal Health Management
Mechanism of Action
Raloxifene HCl selectively binds to estrogen receptors (ER):
- Agonist activity in bone tissue: Promotes bone density maintenance
- Antagonist activity in breast and uterine tissue: Reduces risk of estrogen-dependent cancers
- Balances estrogenic effects without increasing endometrial or breast cancer risk
- Supports cardiovascular health by modulating lipid profiles
Pharmacological Information
- Chemical Name: 6-hydroxy-2-[4-(2-piperidin-1-yl-ethoxy)phenyl]-3-phenyl-4H-chromen-4-one hydrochloride
- Molecular Formula: C28H27NO4·HCl
- Molecular Weight: 473.98 g/mol
- CAS Number: 84449-90-1
- Therapeutic Class: SERM (Selective Estrogen Receptor Modulator)
- Pharmacological Class: Bone Health / Oncology Adjunct
- ATC Code: G03XC01
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in methanol, ethanol; slightly soluble in water |
| Melting Point | 266°C – 270°C |
| pH (1% aqueous solution) | 5.0 – 6.5 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Raloxifene HCl API is used in:
- Tablet formulations for osteoporosis and breast cancer risk reduction
- Combination therapy with calcium and vitamin D
- Pharmaceutical bulk production for domestic and international markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
