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Sodium Alendronate Trihydrate is a potent bisphosphonate API primarily used in the prevention and treatment of osteoporosis, Paget’s disease of bone, and other conditions that lead to bone loss. It works by inhibiting osteoclast-mediated bone resorption, helping to maintain bone density and reduce the risk of fractures in postmenopausal women and elderly patients.
At Bluepill Express, we manufacture and export high-purity Sodium Alendronate Trihydrate API under WHO-GMP, ISO 9001:2015, and cGMP-compliant conditions. Our production process ensures exceptional assay values (≥99%), consistent particle size distribution, and low impurity levels, meeting international pharmacopeial standards (IP/BP/USP/EP).
Sodium Alendronate Trihydrate is widely used by global pharmaceutical formulators for oral tablets and effervescent formulations designed for long-term bone health management. It helps in improving bone strength and mineralization in patients at risk of bone fractures.
Therapeutic Applications:
- Treatment and prevention of osteoporosis in postmenopausal women and men
- Glucocorticoid-induced osteoporosis management
- Paget’s disease of bone
- Osteopenia and metabolic bone disorders
Mechanism of Action:
Sodium Alendronate Trihydrate binds to hydroxyapatite crystals in bone and specifically inhibits osteoclast activity, thereby reducing bone resorption. This results in a net increase in bone mass and strength over time. The drug enhances calcium balance and maintains skeletal integrity.
Technical Specifications:
- Chemical Name: Sodium alendronate trihydrate
- Molecular Formula: C₄H₁₂NNaO₇P₂·3H₂O
- Molecular Weight: 325.12 g/mol
- CAS Number: 121268-17-5
- Appearance: White crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Solubility: Freely soluble in water; practically insoluble in organic solvents
- Storage Conditions: Store below 25°C, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Bisphosphonate / Bone resorption inhibitor
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral tablets (5 mg, 10 mg, 35 mg, 70 mg)
- Effervescent and soluble tablet formulations
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
- High-purity crystalline API with controlled particle size
- HPLC and FTIR-tested for assay and identity verification
- Low impurity profile per ICH Q3A/B standards
- COA, MSDS, and DMF available for global regulatory submission
- Validated manufacturing process ensuring reproducibility and global compliance
Advantages of Bluepill Express Sodium Alendronate Trihydrate:
- Assay ≥99% ensuring consistent bioavailability in finished dosage
- Excellent chemical stability and solubility profile
- DMF-ready documentation for international registrations
- Batch-to-batch consistency under validated manufacturing conditions
- Complies with international pharmacopeial monographs (IP/BP/USP/EP)
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
- Shelf Life: 3 years when stored under recommended conditions
- Labeling: As per pharmacopeial and international export standards
- Export Markets: Europe, Latin America, Africa, Middle East, and Asia-Pacific
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF – available upon request)
- Stability and Validation Reports
