Packaging and storage— Preserve in tight,light-resistant containers.

Labeling— The label states the Latin binomial and,following the official name,the part of the plant source from which the article was derived.

Solubility in 80percent alcohol— One volume dissolves in 8volumes of 80percent alcohol.

Specific gravity á841ñ: between 0.900and 0.910.

Angular rotation á781Añ: between +70and +80.

Refractive index á831ñ: between 1.484and 1.488at 20.

Heavy metals,Method IIá231ñ: 0.004%.

Assay— Transfer 10mLof Oil,accurately measured,to a cassia flask,and add 50mLof a saturated solution of sodium sulfite that has been made neutral to 2drops of phenolphthalein TSby means of a saturated sodium bisulfite solution.Heat the flask in boiling water,and shake it repeatedly,neutralizing the mixture from time to time by adding a few drops of the saturated sodium bisulfite solution.When no coloration appears upon the addition of a few more drops of phenolphthalein TSand heating for 15minutes,cool the mixture to room temperature,and when the liquids have separated more completely,add a sufficient volume of the saturated sodium bisulfite solution to raise the lower level of the oily layer to the graduated portion of the neck of the flask.The volume of the residual oily liquid does not exceed 5mL,indicating the presence of not less than 50.0%(v/v)of d-carvone (C10H14O)in the portion of Oil taken.

Expert Committee:(CRX)Compounding Pharmacy

USP28–NF23Page 2972

Phone Number:1-301-816-8243