Alendronate Sodium (India)

1. NOMENCLATURE : Alendronate Sodium Trihydrate.

: Sodium Alendronate hydrate.



2. CAS NO. : 121268-17-5





3. EMPIRICAL FORMULA : C4H12NNaO7P2, 3H2O.





4. MOL. WT. : 325.1



5. DESCRIPTION : A white or almost white, crystalline

powder, soluble in water, very slightly

soluble in Methanol, practically insoluble

in Methylene Chloride.



6. APPLICATIONS : Inhibition of bone resorption.

:For treatment of postmenopausal

osteoporosis.



7.SOLUBILITY : Soluble in water

:Very slightly soluble in Methanol,

Practically insoluble in Methylene Chloride.



8.CLARITY & COLOR OF : 1 w/v solution is Clear and colourless

SOLUTION





9. pH (1 w/v Soln. : Between 4.0 and 5.0





10. MELTING POINT : 273°C to 277°C





11. 4-AMINOBUTANOIC ACID : NMT 0.5

(By TLC)





12. PHOSPHATE : NMT 0.5



PHOSPHITE : NMT 0.5

(By HPLC)





13. HEAVY METAL : NMT 20 PPM





14. LOSS ON DRYING : 16.1 TO 17.1





15. ASSAY : NLT 98.0 and NMT 102.0 of

(By HPLC) C4H12NNaO7P2, 3H2O on dried basis.