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Alendronate sodium
Alendronate sodium Ph.
Eur.
|
TESTS |
REQUIREMENTS |
METHODS |
Identification: A. IR spectrum
B. chemical reaction |
corresponds to sodium alendronate CRS gives reaction of sodium |
Ph. Eur. |
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Appearance of solution |
clear and not more intensely coloured than reference solution B7 or BY7 |
Ph. Eur. |
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pH |
4.0 to 5.0 |
Ph. Eur. |
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Related substances (HPLC): - impurity A - other single impurity - total impurities |
not more than 0.1% not more than 0.10% not more than 0.5% |
Ph. Eur. |
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Phosphate and Phosphite (HPLC): - phosphate - phosphite |
not more than 0.5% not more than 0.5% |
Ph. Eur. |
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Heavy metals |
not more than 20 ppm |
Ph. Eur. |
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Loss on drying |
16.1% to 17.1% |
Ph. Eur. |
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Content of alendronate sodium calculated on the dried substance (HPLC) |
98.0% - 102.0% |
Ph. Eur. |
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Residual solvents: - methanol |
not more than 500 ppm |
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Information Associated with Product: | ||||||||||||||
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