Sodium Chloride and Dextrose Tablets
»Sodium Chloride and Dextrose Tablets contain not less than 92.5percent and not more than 107.5percent of the labeled amount of sodium chloride (NaCl)and of dextrose (C6H12O6·H2O).
Packaging and storage— Preserve in well-closed containers.
Identification—
A: Afiltered solution of Tablets responds to the flame test for Sodium á191ñand to the test for Chloride á191ñ.
B: Add a few drops of the filtered solution tablets to 5mLof hot alkaline cupric tartrate TS:a copious red precipitate of cuprous oxide is formed.
Uniformity of dosage units á905ñ: meet the requirements.
Assay for sodium chloride— Transfer 20.0mLof the solution prepared for the Assay for dextroseto a 100-mLvolumetric flask,dilute with water to volume,mix,and proceed as directed in the Assayunder Sodium Chloride Tablets,beginning with “Pipet a volume of the solution.”
Assay for dextrose— Dissolve not less than 10Tablets,containing from 2to 5g of dextrose,in about 75mLof water in a 100-mLvolumetric flask,add several drops of 6Nammonium hydroxide,dilute with water to volume,and mix.After 30minutes,filter through a dry filter,and determine the angular rotation in a 200-mm tube at 25,retaining the excess of the solution for the Assay for sodium chloride.The observed rotation in degrees,multiplied by 1.0425,represents the weight,in g,of C6H12O6·H2Oin the specimen taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1782
Pharmacopeial Forum:Volume No.30(5)Page 1647
Phone Number:1-301-816-8379
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