U.S. PHARMACOPEIA

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Compound Orange Spirit
» Compound Orange Spirit contains, in each 100 mL, not less than 25 mL and not more than 30 mL of the mixed oils (see Pharmaceutical Compounding—Nonsterile Preparations 795):
Orange Oil 200 mL
Lemon Oil 50 mL
Coriander Oil 20 mL
Anise Oil 5 mL
Alcohol, a sufficient quantity
to make		 1000 mL
Mix the oils with sufficient Alcohol to make the product measure 1000 mL.
Packaging and storage— Preserve in tight containers, protected from light, and store in a cold place.
Alcohol content, Method I 611: between 65.0% and 70.0% of C2H5OH.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer 2.0 mL of Compound Orange Spirit and 1.0 mL of kerosene to a Babcock bottle, graduated to 8%, and mix. Add sufficient saturated calcium chloride solution, acidified with hydrochloric aid, to almost fill the bulb of the bottle. Rotate the bottle vigorously to ensure mixing, then add a sufficient quantity of the calcium chloride solution to bring the separated oil into the neck of the bottle. Centrifuge for 5 minutes at about 1500 rpm, and read the volume of oil in the stem. Subtract five divisions on the volumetric flask for the kerosene added, and multiply the remaining number of divisions by 10.5 to obtain the volume, in mL, of mixed oils in 100 mL of the Compound Orange Spirit.
Auxiliary Information— Staff Liaison : Claudia C. Okeke, Ph.D., Associate Director
Expert Committee : (CRX05) Compounding Pharmacy05
USP29–NF24 Page 3384
Pharmacopeial Forum : Volume No. 28(5) Page 1466
Phone Number : 1-301-816-8243