Pharmaceutical grade Alendronate Sodium
Product Category: Anti-osteoporosis drugs
English name: Alendronate sodium
Traits: white crystalline powder; odorless, tasteless.
CAS No: 121268-17-5
Molecular weight: 325.12
Molecular formula: C4H12NNaO7P2
Implementation of quality standards: EP / CP
Product registration: DMF
Product Description: Alendronate is the second generation of bisphosphonates, bisphosphonates are bones and hydroxyapatite in combination with pyrophosphate artificial analogues, osteoclast-mediated Bone uptake has a strong inhibitory effect. Alendronic acid selectively binds to the bone resorption site and does not interfere with the repair or attachment of osteoclasts, but inhibits osteoclast activity. Its pharmacological effect is by inhibiting the activity of osteoclasts, strong inhibition of bone resorption, stimulate trabecular bone reconstruction, significantly increased bone mass, so that the loss of bone tissue recovery. It is characterized by strong bone resorption activity without bone mineralization inhibition, increase bone mineral content.
Effective date: 3 years
Packaging specifications: 5kg, 10kg, 25kg / barrel
Storage conditions: placed in a ventilated, cool place, dark, at 2 ºC -8 ºC closed storage
Specification
Description White crystalline powder
Identification (1)physical chemistry reaction,positive reaction
(2) infrared absorption atlas in accord with the reference
Acidity 4.2 ~ 4.6
Chloride ≤ 0.01%
Lose on drying 16.0% - 17.5%
Sodium dihydrogen phosphite ≤ 0.3%
Total impurity ≤ 0.5%
Single impurity ≤ 0.1%
Heavy metal ≤ 10ppm
Assay ≥ 99.0%
Usage
Alendronate sodium is a bisphosphonate drug used for osteoporosis and several other bone diseases. And it used for
prophylaxis and in treatment of female and male osteoporosis. It has been used for prevention and treatment of corticosteroid-associated osteoporosis together with supplements of calcium and vitamin D, and used for paget's disease.
