Caraway Oil
(kar' a way oyl).
DEFINITION
Caraway Oil is the volatile oil distilled from the dried, ripe fruit of Carum carvi L. (Fam. Apiaceae). It contains NMT 50.0% of d-carvone (C10H14O).
ASSAY
•  Procedure
Sample:  10 mL of Caraway Oil
Analysis:  Transfer the Sample 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 min, cool the mixture to room temperature. 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.
Acceptance criteria:  The volume of the residual oily liquid does not exceed 5 mL, indicating the presence of NLT 50.0% of d-carvone (C10H14O) in the portion of Oil taken.
IMPURITIES
•  Heavy Metals, Method II 231: NMT 40 µg/g
SPECIFIC TESTS
•  Solubility in 80% Alcohol: One volume dissolves in 8 volumes of 80% alcohol.
•  Specific Gravity 841: 0.900–0.910
•  Refractive Index 831: 1.484–1.488 at 20
ADDITIONAL REQUIREMENTS
•  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.
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(DS2010) Monographs - Dietary Supplements
USP35–NF30 Page 1728
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