| TESTS |
SPECIFICATIONS |
REFERENCE |
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| 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 |
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| Solubility |
Soluble in water, very slightly soluble in methanol, practically insoluble in methylene chloride. |
BP/EP/USP |
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| 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 |
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| Identification |
It meets the requirements of the flame test for Sodium as per the USP method <191> |
USP |
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| Appearance of solution |
1 % w/v solution is clear and colourless. |
BP/EP |
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| pH (1 % w/v soln.) |
Between 4.0 and 5.0. |
BP/EP |
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| 4-aminobutanoic acid |
To comply the TLC test as per BP ‘2010. |
BP/EP |
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Phosphate Phosphite |
Not more than 0.5% Not more than 0.5% |
BP/EP |
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| Heavy Metals |
Not more than 20 ppm / Not more than 10 ppm |
BP/EP/USP |
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| Chromatographic purity |
Single Impurity : Not more than 0.1 % Total Impurity : Not more than 0.5 %
|
USP |
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| Loss on Drying |
16.1 % to 17.1 % |
BP/EP/USP |
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| Assay |
NLT 98.0 % and NMT 102.0 % of C4H12NNaO7P23H2O, on dried basis. |
BP/EP/USP |