C7H5NaO3 160.10

Benzoic acid,2-hydroxy-,monosodium salt.
Monosodium salicylate [54-21-7].

Packaging and storage— Preserve in well-closed,light-resistant containers.

Identification— Asolution (1in 20)responds to the tests for Sodium á191ñand for Salicylate á191ñ.

Water,Method Iá921ñ: not more than 0.5%.

Sulfite or thiosulfate— Add 1mLof hydrochloric acid to a solution of 1.0g in 20mLof water,and filter the liquid:not more than 0.15mLof 0.10Niodine is required to produce a yellow color in the filtrate.

Heavy metals,Method Iá231ñ— Dissolve 2g in 46mLof water.Add,with constant stirring,4mLof 3Nhydrochloric acid,filter,and use 25mLof the filtrate:the limit is 0.002%.

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Assay— Transfer about 700mg of Sodium Salicylate,accurately weighed,to a 250-mLbeaker.Add 100mLof glacial acetic acid,stir until the sample is completely dissolved,add crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 16.01mg of C7H5NaO3.

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 1793

Phone Number:1-301-816-8143