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