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 C
18H
32CaN
2O
10dissolved,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.
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 C
18H
32CaN
2O
10in 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.