Compound Orange Spirit
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Compound Orange Spirit contains NLT 25 mL and NMT 30 mL of the mixed oils in 100 mL of Spirit.
Prepare Compound Orange Spirit as follows (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..
2 ASSAY
2.1 PROCEDURE
Sample solution: Transfer 2.0 mL of Compound Orange Spirit and 1.0 mL of kerosene to a Babcock bottle, graduated to 8%, and mix.
Analysis: To the Sample solution add sufficient saturated calcium chloride solution, acidified with hydrochloric acid, 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 min at 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.
Acceptance criteria: 25-30 mL
3 OTHER COMPONENTS
ALCOHOL DETERMINATION, Method / (611): 65.0%-70.0%
4 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Package in tight containers, protected from light, and store in a cold place.
