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Specification
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For: Sodium Alendronate BP or 4-Amino 1-Hydroxy Butylidene Bis Phosphonic Acid Mono Sodium Salt Tri Hydrate
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Test
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Specification
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Description
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White crystalline powder, Odourless, Tasteless
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Identification
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A) I. R. Test should complies with IR of standard.
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Solubility
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Soluble in water very slightly soluble in Methanol, practically insoluble in Methylene Chloride
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Appearance of Solution
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Clear and colour less solution
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Heavy Metals
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Limit: Max.20 PPM
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Ph (1% Solution)
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Limit between 4.0 to 5.0 (0.5 Gms in 50 ML Water)
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4 - Amino Butyric Acid (By TLC)
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Limit: Max.0.5%
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Phosphate and Phosphite (By H.P.L.C.)
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Limit: Max.0.5%
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Loss on drying (at 140° C to 145°C)
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Limit: 16.1% to 17.1%
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Assay
(On Dried Basis)
(By H.P.L.C.)
(By Titration)
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Limit: 98% to 102%
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