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

Specific gravity 841: between 0.900 and 0.910.

Angular rotation 781A: between +70 and +80.

Refractive index 831: between 1.484 and 1.488 at 20.

Heavy metals, Method II 231: 0.004%.

Residual solvents 467: meets the requirements.

Assay— Transfer 10 mL of Oil, accurately measured, to a cassia flask, and add 50 mL of a saturated solution of sodium sulfite that has been made neutral to 2 drops of phenolphthalein TS by 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 TS and heating for 15 minutes, 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 5 mL, indicating the presence of not less than 50.0% (v/v) of d-carvone (C10H14O) in the portion of Oil taken.

Expert Committee : (CRX05) Compounding Pharmacy05

USP29–NF24 Page 3292

Phone Number : 1-301-816-8243