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— A solution (1 in 20) responds to the tests for Sodium 191 and for Salicylate 191.

Water, Method I 921: not more than 0.5%.

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

Heavy metals, Method I 231— Dissolve 2 g in 46 mL of water. Add, with constant stirring, 4 mL of 3 N hydrochloric acid, filter, and use 25 mL of the filtrate: the limit is 0.002%.

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

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

Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 1991

Phone Number : 1-301-816-8139