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Description Back to Top
Sodium Alendronate, EP is used to prevent and treat certain types of bone loss (osteoporosis) in adults. All Spectrum Chemical EP grade products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
Specifications Back to Top
Test | Specification | |
---|---|---|
Min | Max | |
ASSAY (DRIED BASIS) | 98.0 - 102.0% | |
APPEARANCE OF SOLUTION | TO PASS TEST | |
pH OF SOLUTION | 4.0 - 5.0 | |
LOSS ON DRYING | 16.1 - 17.1% | |
4-AMINOBUTANOIC ACID | 0.5% | |
PHOSPHATE AND PHOSPHITE | 0.5% | |
HEAVY METALS | 20 ppm | |
RESIDUAL SOLVENTS | TO PASS TEST | |
EXPIRATION DATE |
Shipping & Storage Back to Top