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Bulk Active : Alendronate Sodium
MOLECULAR FORMULA : C4H12NNaO7P2, 3H2O
MOLECULAR WEIGHT : 325.12
Pharmacologic Activity :
Anti-Osteoporosis
CAS No : 121268-17-5
Specifications : BP/EP/USP
Regulatory compliance : eDMF(CTD)
| TEST | USP 36 | BP 2013/EP 7.4 |
| CHARACTERS | White, free-flowing powder. | A white or almost white, crystalline powder, |
| SOLUBILITY | Soluble in water, very slightly soluble in dimethyl sulfoxide, in methyl alcohol, and in propylene glycol; practically insoluble in acetone, in acetonitrile, in alcohol, in chloroform, and in isopropyl alcohol. |
soluble in water, very slightly soluble in methanol, practically insoluble in methylene chloride |
| IDENTIFICATION INFRARED ABSORPTION
Test for sodium |
Infrared absorption spectrum of sample should be concordant with the reference spectrum of Alendronate Sodium Trihydrate It should respond to the test for Sodium. |
Infrared absorption spectrum of sample should be concordant with the reference spectrum of Sodium Alendronate working reference standard. It should respond to the test for Sodium |
| Appearance of solution | ----- | Solution S is clear and not more intensely coloured than reference solution B7 or BY7. |
| pH of Solution S | ----- | Between 4.0 to 5.0 |
| 4-Aminobutanoic acid by TLC | ----- | Any spots corresponding to 4-aminobutanoic acid in the chromatogram obtained with the test solution are not more intense than the spot in the chromatogram obtained with reference solution (b) (0.5 per cent). |
| Phosphate
Phosphite Individual Impurity Total Impurity |
------
------ NMT 0.1% NMT 0.5% |
NMT 0.5% NMT 0.5% ------ ------ |
| LOSS ON DRYING | Between 16.1% to 17.1% W/W | Between 16.1% to 17.1% W/W |
| HEAVY METALS | Not more than 0.001% | NMT 10 ppm |
| ASSAY | Between 98.0% and 102.0% w/w | Between 98.0% and 102.0% w/w |
