11/7/2020 USP-NF Palm Kernel Oil

Printed on: Sat Nov 07 2020, 15:23:16 pm

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© 2020 USPC

Palm Kernel Oil

Elaeis guineensis seed oil
[8023-79-8].

DEFINITION
Palm Kernel Oil is the re ned xed oil obtained from the kernel of the fruit of the oil palm Elaeis guineensis Jacq. (Fam. Arecaceae). It
may contain suitable antioxidants.

IDENTIFICATION
• A. It meets the requirements in Speci c Tests for Fats and Fixed Oils, Fatty Acid Composition 〈401〉.
• B. It meets the requirements in Speci c Tests for Melting Range or Temperature 〈741〉.

IMPURITIES
• LIMIT OF LEAD
[NOTE—For this test, use reagent-grade chemicals with as low a lead content as is practicable, as well as high-purity water and gases.
Before use in this analysis, rinse all glassware and plasticware twice with diluted nitric acid and twice with diluted hydrochloric acid,
and then rinse them thoroughly with Puri ed Water.]
Hydrogen peroxide–nitric acid solution: 10% hydrogen peroxide and diluted nitric acid (1:1). [NOTE—Use caution.]
Lead nitrate stock solution: Dissolve 159.8 mg of lead nitrate in 100 mL of Hydrogen peroxide–nitric acid solution. Dilute with

lead salts. Each mL of this solution contains the equivalent of 100 µg of lead. L
Hydrogen peroxide–nitric acid solution to 1000 mL, and mix. Prepare and store this solution in glass containers that are free from

Standard lead solution: On the day of use, dilute 10.0 mL of Lead nitrate stock solution with Hydrogen peroxide–nitric acid solution to
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100.0 mL, and mix. Each mL of Standard lead solution contains the equivalent of 10 µg of lead.
Butanol–nitric acid solution: Slowly add 50 mL of nitric acid to approximately 500 mL of butanol in a 1000-mL volumetric ask. Dilute
with butanol to volume.
Standard solutions: Into ve separate 100-mL volumetric asks pipet 0.2, 0.5, 1, 2, and 5 mL, respectively, of Standard lead solution,
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and dilute with Butanol–nitric acid solution to volume. The Standard solutions contain 0.02, 0.05, 0.1, 0.2, and 0.5 µg/mL of lead,
respectively.
Sample solution: [CAUTION—Prepare this solution in a fume hood, and wear safety glasses.] Transfer 1.0 g of Oil into a large test tube.
Add 1 mL of nitric acid. Place the test tube in a rack in a boiling water bath. As soon as the rusty tint is gone, add 1 mL of 30%
hydrogen peroxide dropwise to avoid a vigorous reaction, and wait for bubbles to form. Stir with an acid-washed plastic spatula if
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necessary. Remove the test tube from the water bath, and allow it to cool. Transfer the solution to a 10-mL volumetric ask, and
dilute with Butanol–nitric acid solution to volume.
Tungsten solution: Transfer 0.1 g of tungstic acid and 5 g of sodium hydroxide pellets to a 50-mL plastic bottle. Add 5.0 mL of water,
and mix. Heat the mixture in a hot water bath until complete solution is achieved. Cool, and store at room temperature.
Instrumental conditions
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(See Atomic Absorption Spectroscopy 〈852〉.)

Mode: Graphite furnace atomic absorption spectrophotometry
Analytical wavelength: 283.3 nm lead emission line
Injection size: 20 µL
Lamp: Lead hollow-cathode
Furnace conditioning: Place the graphite tube in the furnace. Inject the Tungsten solution into the graphite tube, using an argon ow
rate of 300 mL/min. Maintain the drying temperature at 110° for 20 s, the ashing temperature at 700°–900° for 20 s, and with the
argon ow stopped, the atomization temperature at 2700° for 10 s; repeat this process once more using a second 20-µL aliquot of
the Tungsten solution. Clean the quartz windows.
Analysis
Samples: Standard solutions and Sample solution
[NOTE—The sample injection technique is the most crucial step in controlling the precision of the analysis; the volume of each of
the Standard solutions and the Sample solution must remain constant. Rinse the µL-pipet tip three times with either the Standard
solutions or the Sample solution before injection. Use a fresh pipet tip for each injection, and start the atomization process
immediately after injecting the Samples. Between injections, ush the graphite tube of any residual lead by purging at a high
temperature recommended by the manufacturer.]
Concomitantly determine the absorbances of the Samples.
Atomize equal volumes of the Standard solutions and the Sample solution with an argon ow rate of 300 mL/min.

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11/7/2020 USP-NF Palm Kernel Oil

Maintain the drying temperature of the furnace at 110° for 30 s after a 20-s ramp time and a 10-s hold time; the ashing
temperature at 700° for 42 s after a 20-s ramp time and a 22-s hold time; and the atomization temperature at 2300° for 7 s with
the argon ow stopped.
Plot the absorbance of each of the Standard solutions, compensated for background correction, versus its content of lead, in
µg/mL, and draw the best straight line tting the ve points. From this plot, determine the concentration, C, in µg/mL, of lead in
the Sample solution.
Calculate the quantity, in µg/g, of lead in the portion of Oil taken:

Result = (C/W) × V

C = measured concentration of lead in the Sample solution (µg/mL)

W = weight of the Oil taken to prepare the Sample solution (g)

V = nal volume of the Sample solution, 10 mL

Acceptance criteria: NMT 0.1 µg/g of lead

SPECIFIC TESTS
• FATS AND FIXED OILS, Acid Value 〈401〉: NMT 2.0
• FATS AND FIXED OILS, Fatty Acid Composition 〈401〉: Palm Kernel Oil exhibits the composition pro le of fatty acids shown in Table 1.

Table 1

Carbon-Chain Length Number of Double Bonds Percentage (%)

6 0 ≤1.5

8 0 3–5

10 0
L 2.5–6
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12 0 40–52

14 0 14–18

16 0 7–10
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18 0 1–3

20 0 ≤1
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16 1 ≤1

18 1 11–19

18 2 0.5–4
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• FATS AND FIXED OILS, Peroxide Value 〈401〉: NMT 10.0

• FATS AND FIXED OILS, Unsaponifiable Matter 〈401〉: NMT 1.5%
• MELTING RANGE OR TEMPERATURE 〈741〉: 27°–29°
• WATER DETERMINATION, Method I 〈921〉: NMT 0.1%, 50 mL of chloroform being used instead of 35–40 mL of methanol as the solvent.

ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed containers. Do not store above 45°.
• LABELING: Label it to indicate the name and quantity of any added antioxidants.

Auxiliary Information- Please check for your question in the FAQs before contacting USP.

Topic/Question Contact Expert Committee

PALM KERNEL OIL Peng Zhang CE2020 Complex Excipients

Scienti c Liaison

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11/7/2020 USP-NF Palm Kernel Oil

Chromatographic Database Information: Chromatographic Database

Most Recently Appeared In:

Pharmacopeial Forum: Volume No. 32(5)

Page Information:

USP43-NF38 - 5917
USP42-NF37 - 5860
USP41-NF36 - 5478

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