C14H12O2 212.24

Benzoic acid,phenylmethyl ester.
Benzyl benzoate [120-51-4].

Packaging and storage— Preserve in tight,well-filled,light-resistant containers,and avoid exposure to excessive heat.

USP Reference standards á11ñ— USP Benzyl Benzoate RS.

Identification,Infrared Absorption á197Fñ.

Specific gravity á841ñ: between 1.116and 1.120.

Congealing temperature á651ñ: not lower than 18.0.Congelation may be brought about by addition of a fragment of previously congealed Benzyl Benzoate when the temperature has reached the expected congealing temperature.

Refractive index á831ñ: between 1.568and 1.570at 20.

Aldehyde— Transfer 10.0g to a 125-mLconical flask containing 50mLof alcohol and 5mLof hydroxylamine hydrochloride solution (3.5in 100),mix,and allow to stand for 10minutes.Add 1mLof bromophenol blue TS,and titrate with 0.1Nsodium hydroxide VSto a light green endpoint.Perform a blank determination,and match the color of the endpoint with that of the titrated test solution.The net volume of 0.1Nsodium hydroxide consumed does not exceed 0.50mL(0.05%as benzaldehyde).

Acidity— Add 2drops of phenolphthalein TSto 25mLof alcohol,and add 0.020Nsodium hydroxide until a pink color is produced.Add 5.0g of Benzyl Benzoate,mix,and titrate with 0.020Nsodium hydroxide:not more than 1.5mLof 0.020Nsodium hydroxide is required to restore the pink color.

Organic volatile impurities,Method Vá467ñ: meets the requirements.

Assay— Transfer about 2g of Benzyl Benzoate,accurately weighed,to a conical flask fitted with a reflux condenser,add 50.0mLof 0.5Nalcoholic potassium hydroxide VS,and boil gently for 1hour.Cool,add phenolphthalein TS,and titrate with 0.5Nhydrochloric acid VS.Perform a blank determination (see Residual Titrationsunder Titrimetry á541ñ).Each mLof 0.5Nalcoholic potassium hydroxide is equivalent to 106.1mg of C14H12O2.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 239

Phone Number:1-301-816-8394