Function: | Anti Osteoporosis |
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Grade Standard: | Medicine Grade |
Type: | API |
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Product Name | Alendronate Sodium | CAS No. | 121268-17-5 | |
Molecular Formula | C4H12NaNO7P2 · 3H2O | Analysis According | USP38 | |
Inspection Item | Requirements | Test Results | ||
Appearance | White crystalline powder | Complies | ||
Identification |
A. Infrared spectrum should conform, Reaction of sodium | Complies | ||
B. Should conform | Complies | |||
Chromatographic purity | Should Conform | Complies | ||
Lose on drying | 16.1% - 17.1% | 16.4% | ||
(HPLC) Individual Known Impurity |
Individual impurity≤0.1% | Complies | ||
Sum of impurities≤0.5% | Complies | |||
Heavy metals | ≤ 10ppm | <10ppm | ||
Assay( HPLC) | ≥98.5% | 99.5% |