Edition: BP 2025 (Ph. Eur. 11.6 update)
Benzyl Benzoate Cutaneous Emulsion
DEFINITION
Benzyl Benzoate Application is a cutaneous emulsion. It contains 25% w/v of Benzyl Benzoate in a suitable oil-in-water emulsified basis.
Extemporaneous preparation
The following formula and directions apply.
Benzyl Benzoate 250 g
Emulsifying Wax 20 g
Purified Water, freshly boiled and cooled Sufficient to produce 1000 mL
Melt the Emulsifying Wax, add the Benzyl Benzoate and mix. Pour the mixture into sufficient warm Purified Water to produce 1000 mL and stir thoroughly until cold.
The application complies with the requirements stated under Liquids for Cutaneous Application and with the following requirements.
Content of benzyl benzoate, C14H12O2
23.1 to 26.9% w/v.
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Dissolve 1 g of the application in sufficient of the mobile phase to produce 100 mL and dilute 1 volume of the resulting solution to 50 volumes with the mobile phase.
(2) 0.0050% w/v of benzyl benzoate BPCRS in the mobile phase.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (20 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 μm) (Nucleosil C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 230 nm.
(f) Inject 20 μL of each solution.
MOBILE PHASE
30 volumes of water and 70 volumes of acetonitrile.
DETERMINATION OF CONTENT
Determine the weight per mL of the application, Appendix V G, and calculate the content of C14H12O2, weight in volume, using the declared content of C14H12O2 in benzyl benzoate BPCRS.
