Calcium Glubionate Syrup
»Calcium Glubionate Syrup is a solution containing equimolar amounts of Calcium Gluconate and Calcium Lactobionate or with Calcium Lactobionate predominating.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of calcium (Ca).
Packaging and storage
Preserve in tight containers,at a temperature not exceeding 30
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Identification
A:
Adilution of the Syrup with water (1in 10)responds to the tests for Calcium á191ñ.
B:
Dilute a portion of the Syrup with water to obtain a test solution containing about 0.4mg of calcium per mL.Prepare a Standard solution in water containing 2mg of calcium gluconate and 4mg of calcium lactobionate per mL.Apply separately 5µLof the test solution and 5µLof the Standard solution to a suitable thin-layer chromatographic plate coated with 0.25-mm layer of chromatographic silica gel (see Chromatography á621ñ).Dry the plate in a current of cool air.Place the plate in a suitable chromatographic chamber lined with filter paper and previously equilibrated with a solvent system consisting of a mixture of alcohol,water,ethyl acetate,and ammonium hydroxide (50:30:10:10).Develop the chromatogram until the solvent front has moved about three-fourths of the length of the plate.Remove the plate from the chamber,and dry at 100
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pHá791ñ:
between 3.4and 4.5.
Assay
Transfer an accurately measured portion of Syrup,equivalent to about 70mg of Ca,to a suitable beaker.Add 2mLof 3Nhydrochloric acid,and dilute with water to about 150mL.While stirring with a magnetic stirrer,add about 20mLof 0.05Medetate disodium VSfrom a 50-mLburet.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 2.004mg of calcium (Ca).
Auxiliary Information
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28NF23Page 325
Pharmacopeial Forum:Volume No.27(6)Page 3257
Phone Number:1-301-816-8389
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