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 841: between 0.842 and 0.846.

Angular rotation 781A: between +94 and +99.

Refractive index 831: between 1.472 and 1.474 at 20.

Ultraviolet absorbance— Transfer about 250 mg of Oil, accurately weighed, to a 100-mL volumetric flask, add alcohol to volume, and mix. Record the UV absorption spectrum of this solution from 260 to 400 nm in a 1-cm cell, using alcohol as the blank. Determine the absorbance at the wavelength of maximum absorbance at about 330 nm 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 0.130 for California-type Orange Oil, or not less than 0.240 for Florida-type Orange Oil.

Heavy metals, Method II 231: 0.004%.

Foreign oils— Proceed as directed in the test for Foreign oils under 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 20 is between 0.001 and 0.002 lower than that of the original Oil.

Residual solvents 467: meets the requirements.

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

Expert Committee : (CRX05) Compounding Pharmacy05

USP29–NF24 Page 3384

Phone Number : 1-301-816-8243