Calcium Pantothenate Tablets
»Calcium Pantothenate Tablets contain not less than 95.0percent and not more than 115.0percent of the labeled amount of the dextrorotatory isomer of calcium pantothenate (C18H32CaN2O10).
Packaging and storage— Preserve in tight containers.
Labeling— Label the Tablets to indicate the content of dextrorotatory calcium pantothenate.
Identification—
A: Digest a quantity of powdered Tablets,equivalent to about 150mg of calcium pantothenate,with 15mLof 1Nsodium hydroxide,and filter:the filtrate responds to Identification testBunder Calcium Pantothenate.
B: To 5mLof the filtrate obtained in Identification testAadd 5mLof 1Nhydrochloric acid and 2drops of ferric chloride TS:a strong yellow color is produced.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium: water;900mL.
Apparatus 2: 50rpm.
Time: 45minutes.
Procedure— Determine the amount of C18H32CaN2O10dissolved,employing the procedure set forth in the Assay for calcium pantothenate,Method 1,under Water-Soluble Vitamins Tablets,except to omit the Internal standard preparation,using filtered portions of the solution under test,suitably diluted with Dissolution Mediumif necessary,in comparison with a Standard solution having a known concentration of USP Calcium Pantothenate RSin the same Medium.
Tolerances— Not less than 75%(Q)of the labeled amount of C18H32CaN2O10is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Content of calcium— Weigh and finely powder not fewer than 20Tablets.Accurately weigh a portion of the powder,equivalent to about 500mg of calcium pantothenate,transfer to a suitable crucible,and ignite,gently at first,until free from carbon.Cool the crucible,add 10mLof water,and dissolve the residue by adding sufficient 3Nhydrochloric acid,dropwise,to achieve complete solution.Transfer the solution to a suitable container,dilute with water to 150mL,add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and titrate with 0.05Medetate disodium VSuntil the solution is deep blue in color.Each mLof 0.05Medetate disodium is equivalent to 2.004mg of Ca.The content of Ca found is not less than 7.9%and not more than 9.7%of the weight of C18H32CaN2O10in the Tablets,as determined by the Assay.
Assay— Weigh and finely powder not fewer than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 25mg of calcium pantothenate,and transfer,with the aid of about 50mLof water,to a 1000-mLvolumetric flask.Add 2mLof 1Nacetic acid and 100mLof sodium acetate solution (1in 60),then dilute with water to volume,and mix.Make further accurate dilutions,with water,to a concentration between 0.01µg and 0.04µg of calcium pantothenate per mL.Using this solution as the Assay Preparation,proceed as directed under Calcium Pantothenate Assay á91ñ.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 331
Pharmacopeial Forum:Volume No.30(1)Page 81
Phone Number:1-301-816-8389