Magnesium Carbonate and Citric Acid for Oral Solution
»Magnesium Carbonate and Citric Acid for Oral Solution contains a dry mixture of Magnesium Carbonate and Citric Acid that when constituted as directed in the labeling yields a solution that contains not less than 90.0percent and not more than 110.0percent of the labeled amount of magnesium citrate (C12H14Mg3O4).
Packaging and storage— Preserve in tight containers.
Labeling— The label contains directions for constitution of the powder and states the equivalent amount of magnesium citrate (C12H14Mg3O4)in a given volume of the Oral Solution obtained after constitution.
Microbial limits á61ñ It meets the requirements of the test for absence of Escherichia coliand Salmonellaspecies.
Uniformity of dosage units á905ñ: meets the requirements.
Content of anhydrous citric acid—
Cation-exchange column— Mix 10g of styrene-divinylbenzene cation-exchange resin with 50mLof water in a beaker.Allow the resin to settle,and decant and discard the supernatant until a slurry of resin remains.Pour the slurry into a 15-mm ×30-cm glass chromatographic tube having a pledget of glass wool in the bottom and a stopcock,and allow to settle as a homogeneous bed.Place a pledget of glass wool on the top of the bed.Wash the resin bed with about 100mLof water,closing the stopcock when the water level has just entered the glass wool pledget on the surface above the resin bed.
Test solution— Transfer an accurately measured volume of the constituted Oral Solution,equivalent to about 9g of anhydrous citric acid,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Transfer 5.0mLof the Test solutioncarefully onto the top of the resin bed in the cation-exchange column.Place a 250-mLvolumetric flask below the column,open the stopcock,and allow to flow until the solution has entered the resin bed.Elute the column with 70mLof water at a rate of about 5mLper minute,collecting the eluate in a beaker.Boil the eluate for 1minute,cool,and add 5drops of phenolphthalein TS.Titrate with 0.1Nsodium hydroxide VSto a pink endpoint.Each mLof 0.1Nsodium hydroxide is equivalent to 6.404mg of anhydrous citric acid (C6H8O7).The content of anhydrous citric acid is between 76.6%and 107.8%of the labeled amount of magnesium citrate.
NOTE—Perform the following tests on the Oral Solution obtained after constitution as directed in the labeling.Accurately measure the volume of the constituted Oral Solution.
Other requirements— It responds to the Identificationtests and meets the requirements for Chloride,Sulfate,and Tartaric acidunder Magnesium Citrate Oral Solution.
Assay— Transfer an accurately measured volume of constituted Oral Solution,equivalent to about 18.7g of magnesium citrate (C12H10Ng3O14),to a 1000-mLvolumetric flask.Add 200mLof 1Nhydrochloric acid,swirl,and allow to stand for about 10minutes.Dilute with water to volume,and mix.Stir by mechanical means for about 30minutes.Transfer 10.0mLof this solution to a 250-mLbeaker.Add 10mLof ammonia–ammonium chloride buffer TS,5mLof triethanolamine,0.3mLof eriochrome black TS,and titrate with 0.05Medetate disodium VSuntil the last hint of violet disappears (blue endpoint).Each mLof 0.05Medetate disodium is equivalent to 7.520mg of magnesium citrate (C12H10Mg3O14).
Auxiliary Information— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1167
Phone Number:1-301-816-8251