Sodium Chloride and Dextrose Tablets
» Sodium Chloride and Dextrose Tablets contain not less than 92.5 percent and not more than 107.5 percent of the labeled amount of sodium chloride (NaCl) and of dextrose (C6H12O6·H2O).
Packaging and storage Preserve in well-closed containers.
A: A filtered solution of Tablets responds to the flame test for Sodium 191 and to the test for Chloride 191.
B: Add a few drops of the filtered solution tablets to 5 mL of hot alkaline cupric tartrate TS: a copious red precipitate of cuprous oxide is formed.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Assay for sodium chloride Transfer 20.0 mL of the solution prepared for the Assay for dextrose to a 100-mL volumetric flask, dilute with water to volume, mix, and proceed as directed in the Assay under Sodium Chloride Tablets, beginning with Pipet a volume of the solution.
Assay for dextrose Dissolve not fewer than 10 Tablets, containing from 2 to 5 g of dextrose, in about 75 mL of water in a 100-mL volumetric flask, add several drops of 6 N ammonium hydroxide, dilute with water to volume, and mix. After 30 minutes, pass through a dry filter, and determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 781), retaining the excess of the solution for the Assay for sodium chloride. Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)ARin which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.
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USP32NF27 Page 3572Pharmacopeial Forum: Volume No. 30(5) Page 1647