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Magnesium Gluconate Tablets
»Magnesium Gluconate Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of magnesium gluconate (C12H22MgO14).
Packaging and storage—
Preserve in well-closed containers.
Identification—
Afiltered solution of Tablets,equivalent to magnesium gluconate solution (1in 10),diluted with water where necessary,responds to the Identificationtests under Magnesium Gluconate.
Dissolution á711ñ—
Medium:
water;900mL.
Apparatus 2:
50rpm.
Time:
30minutes.
Procedure—
Determine the amount of C12H22MgO14dissolved,employing atomic absorption spectrophotometry at a wavelength of about 285.2nm,in filtered portions of the solution under test,suitably diluted with water,in comparison with a Standard solution having a known concentration of magnesium in the same Medium.
Tolerances—
Not less than 80%(Q)of the labeled amount of C12H22MgO14is dissolved in 30minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not fewer than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 800mg of magnesium gluconate,transfer to a suitable crucible,and ignite,gently at first,until free from carbon.Cool the crucible,add 25mLof water and 5mLof hydrochloric acid,and stir.Heat on a steam bath for 5minutes,and filter,rinsing the filter with several portions of water.Dilute the combined filtrate and washings with water to about 150mL.Add ammonia–ammonium chloride buffer TSuntil the solution is neutral to litmus.Add 5mLof ammonia–ammonium chloride buffer TSand 0.1mLof eriochrome black TS,and titrate with 0.05Medetate disodium VSto a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 20.73mg of magnesium gluconate (C12H22MgO14).
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1171
Phone Number:1-301-816-8389
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