» Sulisobenzone contains not less than 97.0 percent and not more than 103.0 percent of C14H12O6S, calculated on the anhydrous basis.
Packaging and storage Preserve in tight, light-resistant containers.
Identification, Ultraviolet Absorption 197U
Solution: 10 µg per mL.
Absorptivities, calculated on the anhydrous basis, do not differ by more than 3.0%.
Water, Method I 921: not more than 2.0%.
Assay Accurately weigh about 0.25 g of Sulisobenzone, and dissolve in 5 mL of water in a conical flask. Add 50 mL of dehydrated isopropyl alcohol, titrate with 0.1 N tetrabutylammonium hydroxide VS, and determine the two endpoints potentiometrically. V1 and V2 are the volumes, in mL, of titrant needed to reach the first and second endpoints, respectively. To determine the blank value caused by tertiary amines present as impurities in the titrant, dissolve V1/5 mL of 0.5 N hydrochloric acid VS in 50 mL of dehydrated isopropyl alcohol, and subsequently add (5 V1/5) mL of water. Titrate with 0.1 N tetrabutylammonium hydroxide VS, and determine the two endpoints potentiometrically. V1B and V2B are the volumes, in mL, of titrant needed to reach the first and second endpoints, respectively. The blank value VBV , in mL, is obtained by the formula:
V2B V1BCalculate the percentage of C14H12O6S in the portion of Sulisobenzone taken by the formula:
308.31C[2V1 (V2 VBV)](1/W)(0.001)100in which 308.31 is the molecular weight of Sulisobenzone; C is the concentration, in moles per L, of the 0.1 N tetrabutylammonium hydroxide VS; W is the weight, in g, of Sulisobenzone taken; 0.001 is the conversion factor for converting mL to L; and 100 is the conversion factor to percentage.
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USP32NF27 Page 3639Pharmacopeial Forum: Volume No. 33(3) Page 456