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Aminobenzoate Sodium
» Aminobenzoate Sodium contains not less than 98.5 percent and not more than 101.0 percent of C7H6NNaO2, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11— USP Aminobenzoate Sodium RS.
Identification—
A: Ultraviolet Absorption 197U—
Solution: 1 in 100,000.
Medium: 0.001 N sodium hydroxide.
B: Dissolve about 400 mg in 10 mL of water, add 1 mL of 3 N hydrochloric acid, filter, and wash the precipitate with two 5-mL portions of cold water. Recrystallize from alcohol the precipitate so obtained, and dry at 110 for 1 hour: the p-aminobenzoic acid so obtained melts between 186 and 189.
C: A solution (1 in 100) meets the requirements of the flame test for Sodium 191.
pH 791: between 8.0 and 9.0, in a solution (1 in 20).
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
Volatile diazotizable substances—
Standard solution— Dissolve 10 mg of p-toluidine in 5 mL of methanol in a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 1 mL to a 100-mL volumetric flask, dilute with water to volume, and mix.
Test solution— Transfer 5.0 g of Aminobenzoate Sodium to a suitable flask, and add a volume of 1.25 N sodium hydroxide that is just sufficient to dissolve the test specimen and to render the solution just alkaline to phenolphthalein TS. Dilute with water to 50 mL, and steam-distill the solution, collecting about 95 mL of the distillate in a 100-mL volumetric flask. Dilute with water to volume, and mix.
Procedure— Transfer 20.0-mL portions of the Standard solution and the Test solution to separate 100-mL beakers, and transfer 20.0 mL of water to a third 100-mL beaker to provide the blank. Treat each as follows. Add 5.0 mL of 1 N hydrochloric acid, and cool in an ice bath. Add 2.0 mL of 0.1 M sodium nitrite dropwise, with stirring, allow to stand for 5 minutes for the diazotization reaction to be complete, add quickly to 10.0 mL of a cold solution of guaiacol (freshly prepared by dissolving 0.20 g of guaiacol in 100 mL of 1 N sodium hydroxide), mix, and allow to stand for 30 minutes. Concomitantly determine the absorbances of the solutions at the wavelength of maximum absorbance at about 405 nm, with a suitable spectrophotometer, using the blank to set the instrument: the absorbance of the solution obtained from the Test solution does not exceed that of the solution obtained from the Standard solution, corresponding to not more than 0.002% of volatile diazotizable substances, as p-toluidine.
Chloride 221— A 1.4-g portion shows no more chloride than corresponds to 0.4 mL of 0.020 N hydrochloric acid (0.02%).
Sulfate 221— A 1.4-g portion shows no more sulfate than corresponds to 0.3 mL of 0.020 N sulfuric acid (0.02%).
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 500 mg of Aminobenzoate Sodium, accurately weighed, to a suitable vessel, add 25 mL of water and 25 mL of 3 N hydrochloric acid, mix, and cool in an ice bath. Titrate with 0.1 M sodium nitrite VS, determining the endpoint potentiometrically, using a calomel-platinum electrode system. Each mL of 0.1 M sodium nitrite is equivalent to 15.91 mg of C7H6NNaO2.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 133
Pharmacopeial Forum : Volume No. 28(4) Page 1207
Phone Number : 1-301-816-8139