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Calcium Lactate Tablets
»Calcium Lactate Tablets contain not less than 94.0percent and not more than 106.0percent of the labeled amount of calcium lactate (C6H10CaO6·5H2O).
NOTE—An equivalent amount of Calcium Lactate with less water of hydration may be used in place of C6H10CaO6·5H2Oin preparing Calcium Lactate Tablets.
Packaging and storage—
Preserve in tight containers.
Labeling—
The quantity of calcium lactate stated in the labeling is in terms of calcium lactate pentahydrate.
Identification—
A:
Afiltered solution of Tablets,equivalent to calcium lactate solution (1in 20),responds to the tests for Calcium á191ñ.
B:
Afiltered solution of Tablets,equivalent to calcium lactate solution (1in 20),responds to Identificationtest Bunder Calcium Lactate,1drop of the solution being used.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium:
water;500mL.
Apparatus 1:
100rpm.
Time:
45minutes.
Procedure—
Determine the amount of C6H10CaO6·5H2Odissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances—
Not less than 75%(Q)of the labeled amount of C6H10CaO6·5H2Ois dissolved in 45minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Weigh and finely powder not fewer than 20Tablets.Accurately weigh a portion of the powder,equivalent to about 350mg of C6H10CaO6·5H2O,transfer to a suitable container,and add 150mLof water and 2mLof 3Nhydrochloric acid.Stir,using a magnetic stirrer,for 3to 5minutes.While stirring,add about 30mLof 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 15.42mg of C6H10CaO6·5H2O.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 329
Pharmacopeial Forum:Volume No.30(1)Page 81
Phone Number:1-301-816-8389
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