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Alendronate Sodium

Alendronate sodium is an oral aminobiphoshphante which has been approved in Australia for the treatment of established osteoporosis in post-menopausal women, and is also indicated for the treatment of Paget's disease of the bone.

Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C4H12NNaO7P2.3H2O and its formula weight is 325.12.

Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

[Structure]:

[Formula]:C6H12NNaO7P2.3H2O

[Molecular weight]:325.12

[CASRN]:121268-17-5

[Specification]:USP28

Appearance

white, crystalline, nonhygroscopic powder

Heavy Metals

100ppm max

Identification

IR SPECTRUM

Ethanol

0.5% max

Phosphate and Phosphite

0.5% max

4-Aminobutenoic acid

0.5% max

pH

4.2~4.5

Loss on drying

16.1~17.1%

Assay

99.0%~102%(dry)


 

 
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