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Status: Currently Official on 31-Aug-2023
Official Date: Official as of 01-Dec-2015
Document Type: DIETARY SUPPLEMENTS
DocId: GUID-FECB66EB-F30A-4B57-9616-F08319AF5354_2_en-US
DOI: https://doi.org/10.31003/USPNF_M45052_02_01
DOI Ref: rj2sf
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© 2023 USPC
Powdered Licorice
DEFINITION
Powdered Licorice is Licorice reduced to a fine or very fine powder. It contains NLT 2.5% of glycyrrhizic acid (C42H62O16), calculated on the dried
basis.
IDENTIFICATION
• A. Thin-Layer Chromatographic Identification Test
Standard solution: 5 mg/mL of USP Glycyrrhizic Acid RS in a mixture of alcohol and water (7:3)
Sample solution: 2 g of Powdered Licorice in 10 mL of a mixture of alcohol and water (7:3). Heat by shaking on a water bath for 5 min, cool, and
filter.
Chromatographic system
(See Chromatography 〈621〉, Thin-Layer Chromatography.)
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture (TLC plates)
Application volume: 2 µL
Developing solvent system: Butyl alcohol, glacial acetic acid, and water (7:1:2)
Analysis
Samples: Standard solution and Sample solution
AL
Develop the chromatogram in an unsaturated chamber to a length of 10 cm. Examine the plate under 254-nm light.
Acceptance criteria: The chromatograms show a dark purple zone, among other spots, due to glycyrrhizic acid at an RF value of 0.4.
COMPOSITION
• Content of Glycyrrhizic Acid
Diluent: Alcohol and water (1:1)
I
Solution A: Dilute acetic acid (1:15)
IC
Mobile phase: Acetonitrile and Solution A (2:3)
Standard solution: 0.25 mg/mL of USP Glycyrrhizic Acid RS in Diluent
Sample solution: Transfer 500 mg of Powdered Licorice to a suitable flask. Add 70 mL of Diluent, shake for 15 min, centrifuge, and decant the
supernatant into a 100-mL volumetric flask. Mix the residue with 25 mL of Diluent, shake for 15 min, centrifuge, and add the supernatant to the
volumetric flask. Dilute with Diluent to volume, and filter.
FF
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 15-cm; packing L1
O
Flow rate: 0.6 mL/min
Injection volume: 20 µL
System suitability
Sample: Standard solution
Suitability requirements
Column efficiency: NLT 5000 theoretical plates determined from glycyrrhizic acid
Tailing factor: NMT 2.0 for the glycyrrhizic acid peak
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of glycyrrhizic acid (C42H62O16) in the portion of Powdered Licorice taken:
Result = (rU/rS) × CS × (V/W) × 100
rU = peak area of glycyrrhizic acid from the Sample solution
rS = peak area of glycyrrhizic acid from the Standard solution
CS = concentration of USP Glycyrrhizic Acid RS in the Standard solution (mg/mL)
V = final volume of the Sample solution (mL)
W = weight of Powdered Licorice taken to prepare the Sample solution (mg)
Acceptance criteria: NLT 2.5% on the dried basis
CONTAMINANTS
• Articles of Botanical Origin, Limits of Elemental Impurities〈561〉: Meets the requirements
• Articles of Botanical Origin, Pesticide Residue Analysis 〈561〉: Meets the requirements
SPECIFIC TESTS
• Botanical Characteristics
Macroscopic: Light yellow-brown powder with slight odor and sweet taste
Microscopic: Powdered Licorice reveals parenchyma cells containing starch grains and solitary crystals of calcium oxalate, parenchyma cell
fragments, cork tissue, yellow sclerenchymatous fiber bundles that are accompanied by crystal cell rows, and vessels with reticulate and
scalariform pits.
• Articles of Botanical Origin, Foreign Organic Matter 〈561〉: NMT 2.0%
• Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 2 〈561〉: NLT 25.0%
• Loss on Drying 〈731〉: Dry a sample at 105° for 6 h; it loses NMT 12.0% of its weight.
• Articles of Botanical Origin, Total Ash 〈561〉: NMT 7.0%
• Articles of Botanical Origin, Acid-Insoluble Ash 〈561〉: NMT 2.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage: Store in well-closed containers in a cool, dry place.
• Labeling: The label states the Latin binomial and, following the official name, the part of the plant contained in the article.
• USP Reference Standards 〈11〉
USP Glycyrrhizic Acid RS
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Auxiliary Information - Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
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POWDERED LICORICE Anton Bzhelyansky BDSHM2020 Botanical Dietary Supplements
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Scientific Liaison and Herbal Medicines
Chromatographic Database Information: Chromatographic Database
FF
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 40(5)
Page Information:
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USP43-NF38 - 5120
USP42-NF37 - 5062
USP41-NF36 - 4736
Current DocID: GUID-FECB66EB-F30A-4B57-9616-F08319AF5354_2_en-US
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DOI: https://doi.org/10.31003/USPNF_M45052_02_01
DOI ref: rj2sf
