Anise Oil
(an' is oyl).
DEFINITION
Anise Oil is the volatile oil distilled with steam from the dried, ripe fruit of Pimpinella ansium L. (Fam. Apiaceae) or from the dried ripe fruit of Illicium verum Hook. f. (Fam. Illiciaceae).
[Note—If solid material has separated, carefully warm the Anise Oil until it is completely liquefied, and mix before using. ]
IMPURITIES
•  Heavy Metals, Method II 231: NMT 40 ppm
•  Limit of Phenols
Sample solution:  Recently distilled Anise Oil in 90% alcohol (1 in 3)
Acceptance criteria:  The Sample solution is neutral to moistened litmus paper, and develops no blue or brownish color upon the addition of 1 drop of ferric chloride TS to 5 mL of the solution.
SPECIFIC TESTS
•  Solubility in 90% Alcohol: One volume dissolves in 3 volumes of 90% alcohol.
•  Specific Gravity 841: 0.978–0.988
•  Refractive Index 831: 1.553–1.560 at 20
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in well-filled, tight containers, and avoid exposure to excessive heat.
•  Labeling: The label states the Latin binomial name and, following the official name, the part of the plant source from which the article was derived. The label also states that if solid material has separated, carefully warm the oil until it is completely liquefied, and mix before using.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Robert H. Lafaver, M.S.
Scientific Liaison
1-301-816-8335
(EXC2010) Monographs - Excipients
USP35–NF30 Page 1701
Pharmacopeial Forum: Volume No. 27(4) Page 2789