C14H12O6S 308.31
Benzenesulfonic acid, 5-benzoyl-4-hydroxy-2-methoxy-.
5-Benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid [4065-45-6].

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

USP Reference standards 11— USP Sulisobenzone RS.

Identification, Ultraviolet Absorption 197U—

Residual solvents 467: meets the requirements.

Assay— Accurately weigh about 1 g of Sulisobenzone, and dissolve in 20 mL of water in a conical flask. Add 200 mL of dehydrated isopropyl alcohol, titrate a portion with 0.1 N tetrabutylammonium hydroxide VS, and determine the two endpoints potentiometrically. Calculate the amount, in mg, of C14H12O6S in the portion of Sulisobenzone taken by the formula: in which 308.31 is the empirical weight of sulisobenzone; C is the concentration, in moles per liter, of the 0.1 N tetrabutylammonium hydroxide VS; and V1 and V2 are the volumes, in mL, of titrant needed to reach the first and second endpoints, respectively.

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 2046

Phone Number : 1-301-816-8320