11/9/2020 USP-NF American Ginseng

Printed on: Mon Nov 09 2020, 10:09:18 am

Printed by: Shruti Kharidia
O cial Status: Currently O cial on 09-Nov-2020
O cial Date: O cial as of 1-Dec-2015
Document Type: DIETARY SUPPLEMENTS
DocId: 1_GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US
© 2020 USPC

American Ginseng
DEFINITION
American Ginseng consists of the dried roots of Panax quinquefolius L. (Fam. Araliaceae). It contains NLT 4.0% of total ginsenosides,
calculated on the dried basis.

IDENTIFICATION
• A. THIN-LAYER CHROMATOGRAPHY
Standard solution A: 20 mg/mL of USP Powdered American Ginseng Extract RS in methanol
Standard solution B: 20 mg/mL of USP Powdered Asian Ginseng Extract RS in methanol
Sample solution: Transfer about 1.0 g of nely powdered American Ginseng to a 25-mL ask tted with a re ux condenser. Add 10.0
mL of a mixture of methanol and water (7:13), and heat under re ux for 15 min. Cool, lter, and dilute the ltrate with methanol to
10.0 mL.
Adsorbent: 0.25-mm layer of silica gel, typically 20 cm long (TLC plates)
Application volume: 20 µL
Developing solvent system A: Chloroform, methanol, and water (13:7:2). Use the lower phase.
Developing solvent system B: Butyl alcohol, ethyl acetate, and water (4:1:5). Use the upper phase.
Derivatization reagent: Dissolve 0.5 mL of anisaldehyde in 10 mL of glacial acetic acid, add 85 mL of methanol, mix, and carefully add
5 mL of sulfuric acid.
Analysis
Samples: Standard solution A, Standard solution B, and Sample solution

L
Develop in a chamber containing Developing solvent system A until the solvent front has moved 10.5 cm from the origin. Remove
the plates, and allow to dry. Turn the plates 90°, and develop in a chamber containing Developing solvent system B until the
IA
solvent front has moved 10.5 cm from the origin. Remove the plates, and allow to dry. Spray with Derivatization reagent. Heat
the plates at 105°–110° for 10 min, and examine under white light.
Suitability requirements: The order, from top to bottom, of ginsenosides on the chromatographic plates is Rg2 (on left) and Rg1 (on
right), Rf, Re, Rd, Rc, Rb2 (on left) and Rb1 (on right), and Ro. Ginsenosides Rg2, Rg1, Rf, Re, and Rd are found on the upper half of the
IC

plates; the remaining ginsenosides are found on the lower half after chromatographing with Developing solvent system B. Standard
solution A does not exhibit a spot for ginsenoside Rf. Standard solution B exhibits a spot for ginsenoside Rf.
Acceptance criteria: The spots from the Sample solution correspond to those from Standard solution A.
• B. The retention times of the peaks for ginsenosides Rg1, Re, Rb1, Rb2, Rc2, and Rd of the Sample solution correspond to those of
FF

Standard solution A, as obtained in the test for Content of Ginsenosides. The ratio of the peak responses for ginsenosides Rb2 to Rb1 is
less than 0.4, and the ratio of the peak responses for ginsenosides Rg1 to Rb1 is less than 0.3. The chromatogram shows no signi cant
peak at the retention time corresponding to that for ginsenoside Rf of Standard solution B, as obtained in the test for Content of
Ginsenosides.

COMPOSITION
O

• CONTENT OF GINSENOSIDES
Solution A: Water
Solution B: Acetonitrile and water (4:1)
Mobile phase: See Table 1.

Table 1

Time (min) Solution A (%) Solution B (%)

0 76 24

12 76 24

28 65 35

51.5 56.5 43.5

52.5 0 100

https://online.uspnf.com/uspnf/document/1_GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US?source=TOC 1/3
11/9/2020 USP-NF American Ginseng

Time (min) Solution A (%) Solution B (%)

64.5 76 24

77 76 24

Diluent: Alcohol and water (4:6)

Standard solution A: Transfer a quantity of USP Powdered American Ginseng Extract RS, equivalent to about 2 mg of ginsenoside Rb1,
to a suitable container, and dissolve in 10.0 mL of Diluent.
Standard solution B: Transfer a quantity of USP Powdered Asian Ginseng Extract RS, equivalent to about 2 mg of ginsenoside Rg1, to a
suitable container, and dissolve in 10.0 mL of Diluent.
Sample solution: Reduce 100 g of American Ginseng to a powder, and transfer about 1.0 g of the powder, accurately weighed, to a
100-mL round-bottom ask tted with a re ux condenser. Add 50 mL of Diluent and a few grains of pumice, boil on a water bath
under re ux for 1 h, cool, and lter. Wash the ask and the residue with 20 mL of Diluent, and pass through the same lter. Combine
the ltrates, and evaporate in a rotary evaporator at 50° to dryness. Dissolve the residue in 10.0 mL of Diluent.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 203 nm
Analytical column: 4.6-mm × 15-cm; 3-µm packing L1
Guard column: 4.6-mm × 2.0-cm; packing L1
Column temperature: 25°
Flow rate: 1.5 mL/min
Injection size: 10 µL
System suitability
Sample: Standard solution B
Suitability requirements
L
Chromatogram similarity: The chromatogram is similar to the reference chromatogram provided with the lot of USP Powdered
IA
American Ginseng Extract RS being used.
Relative standard deviation: NMT 2.0%, determined for the sum of the peak areas for the six major ginsenosides, in replicate
injections
Analysis
IC

Samples: Standard solution A, Standard solution B, and Sample solution

Identify ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd in the Standard solutions and the Sample solution by comparing the
chromatograms with the reference chromatogram provided with USP Powdered American Ginseng Extract RS, and measure the
peak responses.
Calculate the percentages of individual ginsenosides in the portion of American Ginseng taken:
FF

Result = (rU/rS) × CS × (V/W) × 100

rU = peak response of ginsenoside Rg1, Re, Rb1, Rc, Rb2, or Rd from the Sample solution

rS = peak response of ginsenoside Rg1, Re, Rb1, Rc, Rb2, or Rd from the appropriate Standard solution
O

CS = concentration of ginsenoside Rg1, Re, Rb1, Rc, Rb2, or Rd in the appropriate Standard solution (mg/mL)

V = volume of the Sample solution (mL)

W = weight of American Ginseng taken to prepare the Sample solution (mg)

Calculate the percentage of total ginsenosides in the portion of American Ginseng taken by adding the individual percentages.
Acceptance criteria: NLT 4.0% of total ginsenosides 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
• MICROBIAL ENUMERATION TESTS 〈2021〉: The total aerobic microbial count does not exceed 104 cfu/g. The total combined molds and yeasts
count does not exceed 102 cfu/g.
• ABSENCE OF SPECIFIED MICROORGANISMS 〈2022〉: It meets the requirements of the tests for absence of Salmonella species and Escherichia
coli.

SPECIFIC TESTS
• BOTANICAL CHARACTERISTICS

https://online.uspnf.com/uspnf/document/1_GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US?source=TOC 2/3
11/9/2020 USP-NF American Ginseng

Macroscopic: Fusiform or cylindrical roots, sometimes branched, typically 1–10 cm, sometimes up to 20 cm, in length and up to 2.5
cm in diameter at the crown, with one or more stem scars. Externally pale yellow to golden, rough-textured, with prominent
horizontal rings and ne longitudinal ridges as a result of drying. Root scars or ne rootlets are present. If stem base is present,
scales are thin and perishing (differs from P. ginseng, in which scales at base of stem are eshy and persistent). Fracture is short;
fractured surface is white to ivory, with distinct aromatic odor and rings of secretory canals present in secondary phloem.
Microscopic
Transverse section of root: Multiple layers of thin-walled cork cells are present. Secondary phloem is characterized by conspicuous
air lacunae; abundant, starch-containing storage parenchyma; few sieve elements, found in small groupings; and rings of
schizogenous secretory canals. Each secretory canal is lined with 6–8 epithelial cells that lack starch. Xylem is characterized by
abundant starch-containing storage parenchyma and a few tracheary elements, composed of nonligni ed tracheids and slightly
ligni ed spiral or reticulated vessels lacking secretory canals and found in isolation or in small groupings. Druse crystals are
sometimes present within vascular parenchyma cells. Diarch or triarch primary xylem is in center of root.
• ARTICLES OF BOTANICAL ORIGIN, Foreign Organic Matter〈561〉: NMT 2.0%
• LOSS ON DRYING 〈731〉
Sample: 1.0 g of American Ginseng, nely powdered
Analysis: Dry the Sample at 105° for 2 h.
Acceptance criteria: NMT 10.0%
• ARTICLES OF BOTANICAL ORIGIN, Total Ash〈561〉: NMT 8.0%

ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight, light-resistant containers, and store protected from heat.
• LABELING: The label states the Latin binomial and, following the o cial name, the parts of the plant contained in the article.
• USP REFERENCE STANDARDS 〈11〉
USP Powdered American Ginseng Extract RS
USP Powdered Asian Ginseng Extract RS

Auxiliary Information- Please

Topic/Question Contact
L
check for your question in the FAQs before contacting USP.

Expert Committee
IA
AMERICAN GINSENG ROOT AND Cuiying Ma BDSHM2020 Botanical Dietary
RHIZOME Senior Scienti c Liaison Supplements and Herbal Medicines
IC

Chromatographic Database Information: Chromatographic Database

Most Recently Appeared In:

Pharmacopeial Forum: Volume No. 45(4)
FF

Page Information:

USP43-NF38 - 4750
USP42-NF37 - 4706
USP41-NF36 - 4422

Current DocID: GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US

O

https://online.uspnf.com/uspnf/document/1_GUID-36E825A7-206A-4E78-AB9B-9A3DE1A0A8C2_1_en-US?source=TOC 3/3