GUID - 3 en-US
GUID - 3 en-US
GUID - 3 en-US
Printed by: Rock Pharma Official Date: Official as of 01-Jan-2018 Document Type: NF @2023 USPC
Do Not Distribute DOI Ref: do8dv DOI: https://doi.org/10.31003/USPNF_M44470_03_01
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Blank: Alcohol
Lemon Oil Instrumental conditions
DEFINITION (See Ultraviolet-Visible Spectroscopy á857ñ.)
Lemon Oil is the volatile oil obtained by expression, without Mode: UV-Vis
the aid of heat, from the fresh peel of the fruit of Citrus x limon Spectral range: 260–400 nm
(L.) Osbeck (Fam. Rutaceae), with or without the previous Analysis
separation of the pulp and the peel. The total aldehyde Samples: Sample solution and Blank
content, calculated as citral (C10H16O), is NLT 2.2% and NMT Record the spectrum in a 1-cm cell, and determine the
absorbance at the wavelength of maximum absorbance
3.8% for California-type Lemon Oil, and NLT 3.0% and NMT
at about 315 nm using the line drawn tangent to the
5.5% for Italian-type Lemon Oil.
curves appearing as minima in the spectrum in
[NOTE—Do not use Lemon Oil that has a
wavelength regions above and below the maximum
terebinthine odor.]
wavelength as the baseline.
ASSAY Acceptance criteria: The absorbance, calculated on the
• TOTAL ALDEHYDE CONTENT basis of a 250-mg specimen, is NLT 0.20 for California-type
Reagent solution: Dissolve 4.5 g of hydroxylamine Lemon Oil or NLT 0.49 for Italian-type Lemon Oil.
hydrochloride in 13 mL of water. Add 85 mL of tertiary butyl • FOREIGN OILS: Place 50 mL of Oil in a four-bulb Ladenburg
alcohol, mix, and adjust with 0.5 N potassium hydroxide flask having the following dimensions: the lower or main
to a pH of 3.4. bulb is about 6 cm in diameter, and the smaller condensing
Sample: 5 mL bulbs are about 3.5, 3.0, and 2.5 cm in diameter; the
Analysis: Pipet 50 mL of the Reagent solution into a conical distance from the bottom of the flask to the side-arm is
flask containing the Sample. Insert the stopper in the flask, about 20 cm. Distill Oil at a rate of 1 drop/s until the
al
and allow to stand at room temperature for 30 min, with distillate measures 5 mL: the angular rotation of the first
occasional shaking. Titrate the liberated hydrochloric acid 5 mL is NMT 6° less than that of the original Oil. The
with 0.5 N alcoholic potassium hydroxide VS to a pH of 3.4. refractive index at 20° of this same portion is 0.001–0.003
Each mL of 0.5 N alcoholic potassium hydroxide consumed lower than that of the original Oil.
in the titration is equivalent to 76.12 mg of total aldehydes,
ADDITIONAL REQUIREMENTS
calculated as citral (C10H16O).
Acceptance criteria: The total aldehyde content, calculated
as citral (C10H16O), is 2.2%–3.8% for California-type Lemon
Oil or 3.0%–5.5% for Italian-type Lemon Oil.
ci • PACKAGING AND STORAGE: Preserve in well-filled, tight
containers, and avoid exposure to excessive heat.
• LABELING: The label states the Latin binomial and, following
the official name, the part of the plant source from which
SPECIFIC TESTS the article was derived. Label it to also indicate whether it
ffi
• SPECIFIC GRAVITY á841ñ: 0.849–0.855 is California-type or Italian-type Lemon Oil. The label
• OPTICAL ROTATION, Angular Rotation á781Añ: +57° to indicates that Oil is not to be used if it has a
+65.6° terebinthine odor.
• REFRACTIVE INDEX á831ñ: 1.473–1.476 at 20°
• ULTRAVIOLET ABSORBANCE
Sample solution: Dilute 250 mg of Oil to 100 mL with
O
alcohol
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