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

Labeling— The label states the Latin binomial and,following the official name,the part of the plant source from which the article was derived.Label it also to indicate whether it is California-type or Florida-type Orange Oil.The label indicates that Oil is not to be used if it has a terebinthine odor.

Specific gravity á841ñ: between 0.842and 0.846.

Angular rotation á781Añ: between +94and +99.

Refractive index á831ñ: between 1.472and 1.474at 20.

Ultraviolet absorbance— Transfer about 250mg of Oil,accurately weighed,to a 100-mLvolumetric flask,add alcohol to volume,and mix.Record the UVabsorption spectrum of this solution from 260to 400nm in a 1-cm cell,using alcohol as the blank.Determine the absorbance at the wavelength of maximum absorbance at about 330nm using the line drawn tangent to the curves appearing as minima in the spectrum in wavelength regions above and below the maximum wavelength as the baseline.The absorbance,calculated on the basis of a 250-mg specimen,is not less than 0.130for California-type Orange Oil,or not less than 0.240for Florida-type Orange Oil.

Heavy metals,Method IIá231ñ: 0.004%.

Foreign oils— Proceed as directed in the test for Foreign oilsunder Lemon Oil,except to use Orange Oil instead of Lemon Oil.The angular rotation of the distillate does not differ from that of the original Oil by more than 2,and the refractive index at 20is between 0.001and 0.002lower than that of the original Oil.

Assay— Proceed as directed in the Assayunder Lemon Oil,except to use 5mLof Orange Oil instead of Lemon Oil.Each mLof 0.5Nalcoholic potassium hydroxide consumed in the titration is equivalent to 78.13mg of total aldehydes,calculated as decanal (C10H20O).

Expert Committee:(CRX)Compounding Pharmacy

USP28–NF23Page 3044

Phone Number:1-301-816-8243