Specification :

1. CAS RN: 121268-17-5
2. Structural Formula:

3. Molecular formula & molecular weight: C4H12NNaO7P2• 3H2O 325.12
4. Appearance: It is a white crystal powder, odorless, tasteless, sparingly soluble in water, soluble in hot water, insoluble in ethanol or acetone, freely soluble in sodium hydrate test solution.
5. Quality Standard: BP2005 EP5.0 USP29
Identification A.IR Spectrum spectrophotometry To match with Reference Standard
B. Reaction of physics and chemistry. It gives reaction of sodium.
Tests pH Between 4.2 to 5.0
4-aminobutanoic acid Not more than 0.5%
Phosphate and Phosphite Not more than 0.5%
Heavy metals Not more than 10 ppm
Loss on drying The loss between 16.1% ~ 17.1%
Assay
Sodium Alendronate contains not less than 98.0% and not more than the equivalent of 102.0 of ( 4-amino-1-hydroxybutylidene) bispho-sphonic acid monosodium salt, calculated with reference to the dried substance.
6. Usage: It is a new medicine that cure osteoporosis.
7. Storage: It should be kept in room temperature, stored in sealed containers.
8. Packing: Paper bucket, 10kg package, 20kg package.