| TESTS |
SPECIFICATIONS |
REFERENCE |
| |
| Description |
Transfer approximately 5 gm of the sample to clean, dry watch glass and examine visually. It should be a white or almost white, crystalline powder’
|
BP/EP/USP |
|
| |
| Solubility |
Soluble in water, very slightly soluble in methanol, practically insoluble in methylene chloride. |
BP/EP/USP |
| |
| Identification |
(A) The infrared absorption spectrum is concordant with the reference spectrum of sodium Alendronate / To comply infrared absorption spectrophotometry as per the USP method <197M>.
|
BP/EPUSP |
| (B) It gives reaction of sodium - a dense, white precipitate is produced. |
BP/EP |
| |
| Identification |
It meets the requirements of the flame test for Sodium as per the USP method <191> |
USP |
| |
| Appearance of solution |
1 % w/v solution is clear and colourless. |
BP/EP |
| |
| pH (1 % w/v soln.) |
Between 4.0 and 5.0. |
BP/EP |
| |
| 4-aminobutanoic acid |
To comply the TLC test as per BP ‘2010. |
BP/EP |
| |
Phosphate
Phosphite |
Not more than 0.5%
Not more than 0.5% |
BP/EP |
| |
| Heavy Metals |
Not more than 20 ppm / Not more than 10 ppm |
BP/EP/USP |
| |
| Chromatographic purity |
Single Impurity : Not more than 0.1 %
Total Impurity : Not more than 0.5 %
|
USP |
| |
| Loss on Drying |
16.1 % to 17.1 % |
BP/EP/USP |
| |
| Assay |
NLT 98.0 % and NMT 102.0 % of C4H12NNaO7P23H2O, on dried basis. |
BP/EP/USP |
