31/1/24, 15:44 USP-NF Asian Ginseng

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BRIEFING
Asian Ginseng, USP 42 page 4730. As part of the USP monograph modernization effort, it is proposed to make the following changes:
1. Change the monograph title to Asian Ginseng Root and Rhizome to align with the Dietary Supplements Nomenclature Guideline.

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2. Replace the TLC method with a new HPTLC method for Identification A. Change Standard solution to Standard solution A prepared using
USP Ginsenoside Rg1 RS and USP Ginsenoside Rb1 RS instead of arbutin and escin. Add Standard solution B.
3. Replace the HPLC method with a new UHPLC method for Identification B and the test for Content of Ginsenosides. USP Ginsenoside Rg1 RS

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and USP Ginsenoside Rb1 RS are used for quantitation instead of USP Powdered Asian Ginseng Extract RS to determine the total
ginsenosides as the sum of ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, and Rd. The original Standard solution is changed to Standard solution B
for peak identification. Validation data for the liquid chromatographic procedure in the test for Content of Ginsenosides were obtained using
the Phenomenex Kinetex C18 brand of column with L1 packing. The typical retention times for ginsenoside Rg1, ginsenoside Re,
ginsenoside Rf, chikusetsusaponin V (ginsenoside Ro), ginsenoside Rb1, malonyl ginsenoside Rb1, ginsenoside Rc, ginsenoside Rb2, and

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ginsenoside Rd are 3.6, 3.8, 6.8, 10.9, 11.4, 11.8, 12.3, 13.2, and 14.8 min, respectively.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(BDSHM: C. Ma.)
Correspondence Number—C203457

Change to read:
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Asian Ginseng ▲Root and Rhizome▲ (USP 1-Dec-2020)
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DEFINITION
Change to read:
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Asian Ginseng ▲Root and Rhizome▲ (USP 1-Dec-2020) consists of the dried roots ▲and rhizomes▲ (USP 1-Dec-2020) of Panax ginseng C.A. Mey.

(Family Araliaceae). It contains ▲NLT 0.8% of total ginsenosides calculated as the sum of ginsenoside Rg1 (C42H72O14), ginsenoside Re
(C48H82O18), ginsenoside Rf (C42H72O14), ginsenoside Rb1 (C54H92O23), ginsenoside Rc (C53H90O22), ginsenoside Rb2 (C53H90O22), and ginsenoside

Rd (C48H82O18);▲ (USP 1-Dec-2020) NLT 0.2% of ginsenoside Rg1▲0.3% of the sum of ginsenosides Rg1 and Re;▲ (USP 1-Dec-2020) and NLT
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0.1%▲0.2%▲ (USP 1-Dec-2020) of ginsenoside Rb1, both calculated▲▲ (USP 1-Dec-2020) on the dried basis.

IDENTIFICATION
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Change to read:

• A. Thin-Layer Chromatography▲HPTLC for Articles of Botanical Origin 〈203〉▲ (USP 1-Dec-2020)

Standard solution ▲A:▲ (USP 1-Dec-2020) 5 mg/mL each of arbutin and escin▲0.5 mg/mL each of USP Ginsenoside Rg1 RS and USP Ginsenoside
Rb1 RS▲ (USP 1-Dec-2020) in methanol.
▲Standard solution B:
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10 mg/mL of USP Powdered Asian Ginseng Extract RS in methanol. Sonicate for 15 min, centrifuge, and use the
supernatant.▲ (USP 1-Dec-2020)

Sample solution: ▲Transfer▲ (USP 1-Dec-2020) 1.0 g of finely powdered Asian Ginseng in a 25-mL flask fitted with a reflux condenser. Add 10.0 mL
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of a mixture of methanol and water (7:3), and heat under reflux for 15 min. Cool, filter, and dilute the filtrate with methanol to 10.0 mL.▲Root
and Rhizome in 5.0 mL of alcohol, sonicate for 15 min, centrifuge, and use the supernatant.▲ (USP 1-Dec-2020)
Chromatographic system
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31/1/24, 15:44 USP-NF Asian Ginseng

Adsorbent: 0.25-mm layer of chromatographic silica gel, typically 20 cm long (TLC plates)▲Silica gel with fluorescence indicator F254,
precoated plate, for HPTLC▲ (USP 1-Dec-2020)

Application volume: 20 µL, as▲3 µL, as 8-mm▲ (USP 1-Dec-2020) bands

▲Relative humidity: Condition the plate to a relative humidity of about 33% using a suitable device.
Temperature: About 25°▲ (USP 1-Dec-2020)
Developing solvent system: The upper layer of a mixture of butyl alcohol, ethyl acetate, and water (10:2.5:5) in an unsaturated

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chamber▲Methylene chloride, anhydrous ethanol, and water (60: 45: 6.5)▲ (USP 1-Dec-2020)

Spray▲Derivatization▲ (USP 1-Dec-2020) reagent: Dissolve 0.5 mL of anisaldehyde in 10 mL of glacial acetic acid, add 85 mL of methanol, mix,

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and carefully add 5 mL of sulfuric acid, and mix.▲10% sulfuric acid in alcohol. [Note—Prepare fresh. Slowly add sulfuric acid to ice-cold
alcohol.]▲ (USP 1-Dec-2020)
Analysis

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Samples: Standard solution ▲A, Standard solution B,▲ (USP 1-Dec-2020) and Sample solution
Develop the chromatograms until the solvent front has moved up about three-fourths of the length of the plate. Remove the plate from the
chamber, mark the solvent front, and allow the plate to dry. Spray with Spray reagent. Heat the plate at 105°–110° for 10 min, and examine
the plate under white light.▲Apply the Samples as bands and dry in air. Develop in a saturated chamber, remove the plate from the
chamber, and dry in air. Treat the plate with Derivatization reagent, heat at 105° for 10 min, and examine immediately under white light and

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UV light at 365 nm.▲ (USP 1-Dec-2020)
System suitability
Samples: Standard solution A and Standard solution B

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Suitability ▲requirements▲ (USP 1-Dec-2020) : The Standard solution chromatogram shows, in the upper third, a brown zone corresponding to
arbutin, and in the lower third, a gray zone corresponding to Tescin.
Under white light: Standard solution A exhibits a reddish-violet band due to ginsenoside Rb1 in the lower-third section, and a brown band
due to ginsenoside Rg1 in the middle-third section. In the lower-third section, Standard solution B exhibits a band corresponding in RF and

color to ginsenoside Rb1 in Standard solution A, two to three reddish-violet bands below ginsenoside Rb1, a dark brown band immediately
above ginsenoside Rb1, and a brown band above the dark brown band due to ginsenoside Rc. In the middle-third section, Standard solution
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B exhibits four brown bands, separately due to ginsenoside Rd, ginsenoside Re, ginsenoside Rf, and ginsenoside Rg1 with increasing RF; the
latter corresponds in RF and color to ginsenoside Rg1 in Standard solution A.
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Under UV light at 365 nm: Standard solution A exhibits a reddish-blue band due to ginsenoside Rb1 in the lower-third section, and a pinkish-
violet band due to ginsenoside Rg1 in the middle-third section. In the lower-third section, Standard solution B exhibits a band corresponding

in RF and color to ginsenoside Rb1 in Standard solution A, two to three reddish-blue bands below ginsenoside Rb1, a black band
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immediately above ginsenoside Rb1, and a blue band above the black band due to ginsenoside Rc. In the middle-third section, Standard
solution B exhibits a blue band due to ginsenoside Rd and three pinkish-violet bands above ginsenoside Rd, separately due to ginsenoside
Re, ginsenoside Rf, and ginsenoside Rg1 with increasing RF; the latter corresponds in RF and color to ginsenoside Rg1 in Standard solution
A.▲ (USP 1-Dec-2020)
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Acceptance criteria: The Sample solution exhibits violet-gray zones corresponding to ginsenoside Rg1 in the upper portion and to ginsenoside
Re in the middle and in between the zones corresponding to arbutin and escin in the Standard solution. A violet-gray zone corresponding to
ginsenoside Rb1 is located at the same RF value as the gray zone corresponding to escin in the Standard solution. Other, less intense bands
may be observed between the zones due to ginsenosides Rb1 and Re, and the zone closest to the origin corresponds to ginsenoside Rc. Other

spots may be visible in the lower third of the chromatogram.

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▲Under white light: In the lower-third section, the Sample solution exhibits a band corresponding in RF and color to ginsenoside Rb1 in

Standard solution A and Standard solution B, two to three reddish-violet bands below ginsenoside Rb1, a dark brown band immediately above
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ginsenoside Rb1, and a brown band above the dark brown band due to ginsenoside Rc (distinction from P. notoginseng root and rhizome),
corresponding in RF and color to the same constituents in Standard solution B. In the middle-third section, the Sample solution exhibits four
brown bands corresponding in RF and color to the same constituents in Standard solution B, separately due to ginsenoside Rd, ginsenoside
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Re, ginsenoside Rf (distinction from P. quinquefolius root and rhizome), and ginsenoside Rg1 with increasing RF; the latter corresponds in RF
and color to ginsenoside Rg1 in Standard solution A.

Under UV light at 365 nm: In the lower-third section, the Sample solution exhibits a band corresponding in RF and color to ginsenoside Rb1 in
Standard solution A and Standard solution B, two to three reddish-blue bands below ginsenoside Rb1, a black band immediately above

ginsenoside Rb1, and a blue band above the black band due to ginsenoside Rc (distinction from P. notoginseng root and rhizome),
corresponding in RF and color to the same constituents in Standard solution B. In the middle–third section, the Sample solution exhibits four

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bands corresponding in RF and color to the same constituents in Standard solution B, including a blue band due to ginsenoside Rd and three
pinkish-violet bands above ginsenoside Rd, separately due to ginsenoside Re, ginsenoside Rf (distinction from P. quinquefolius root and
rhizome), and ginsenoside Rg1 with increasing RF; the latter corresponds in RF and color to ginsenoside Rg1 in Standard solution A.▲ (USP 1-

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Dec-2020)
Change to read:

• B. ▲HPLC▲ (USP 1-Dec-2020) : The retention times of the peaks for ginsenosides Rg1, Re, Rf, Rb1, Rc, and Rd in the Sample solution chromatogram

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correspond to those in the Standard solution, as obtained in the test for Content of Ginsenosides Rb1 and Rg1. The ratio of the peak area for

ginsenoside Rb2 to the peak area for ginsenoside Rb1 is NLT 0.4 (differentiation from American ginseng).
▲
Analysis: Proceed as directed in the test of Content of Ginsenosides.
Acceptance criteria: The Sample solution exhibits peaks corresponding to the retention times of ginsenoside Rg1 and ginsenoside Rb1 in

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Standard solution A and Standard solution B. The Sample solution exhibits peaks due to ginsenoside Re, ginsenoside Rf (absent in the roots
and rhizomes of P. quinquefolius and P. notoginseng), chikusetsusaponin V (ginsenoside Ro), malonyl ginsenoside Rb1, ginsenoside Rc,
ginsenoside Rb2 (distinction from P. notoginseng root and rhizome; it does not contain chikusetsusaponin V and ginsenosides Rc and Rb2),

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and ginsenoside Rd corresponding to the retention times of the same ginsenosides in Standard solution B. The content ratio of ginsenoside
Rb2 to ginsenoside Rb1 is NLT 0.3 (differentiation from P. quinquefolius root and rhizome). Malonyl ginsenoside Rb1 peak is between
ginsenoside Rb1 and ginsenoside Rc with peak intensity similar to that of ginsenoside Rc; one peak between ginsenoside Rc and ginsenoside
Rb2 is due to malonyl ginsenoside Rc; one peak between ginsenoside Rb2 and ginsenoside Rd is due to malonyl ginsenoside Rb2 (distinction
from P. ginseng steamed root and rhizome that does not contain significant peaks due to malonyl ginsenosides); and these peaks correspond
to the retention times for the same peaks in Standard solution B. The peak intensity of ginsenoside Rd is less than that of ginsenoside Rb2
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(differentiation from aerial parts of P. ginseng).▲ (USP 1-Dec-2020)
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COMPOSITION
Change to read:

• Content of Ginsenosides Rb1 and Rg1▲▲ (USP 1-Dec-2020)

Solution A: ▲0.003% phosphoric acid in▲ (USP 1-Dec-2020) water

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Solution B: Acetonitrileand water (4:1)▲▲ (USP 1-Dec-2020)

Mobile phase: See Table 1.

Table 1
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Time Solution A Solution B

(min) (%) (%)

0 76▲83▲ (USP 1-Dec-2020) 24▲17▲ (USP 1-Dec-2020)

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12▲0.5▲ (USP 1-Dec-2020) 76▲83▲ (USP 1-Dec-2020) 24▲17▲ (USP 1-Dec-2020)

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28▲3.5▲ (USP 1-Dec-2020) 65▲81▲ (USP 1-Dec-2020) 35▲19▲ (USP 1-Dec-2020)

51.5▲5.0▲ (USP 1-Dec-2020) 56.5▲77▲ (USP 1-Dec-2020) 43.5▲23▲ (USP 1-Dec-2020)

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Time Solution A Solution B

(min) (%) (%)

52.5▲15.0▲ (USP 1-Dec-2020) 0▲70▲ (USP 1-Dec-2020) 100▲30▲ (USP 1-Dec-2020)

64.5▲16.0▲ (USP 1-Dec-2020) 76▲70▲ (USP 1-Dec-2020) 24▲30▲ (USP 1-Dec-2020)

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77▲16.1▲ (USP 1-Dec-2020) 76▲5▲ (USP 1-Dec-2020) 24▲95▲ (USP 1-Dec-2020)

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▲20.0 5 95▲ (USP 1-Dec-2020)

▲20.1 83 17▲ (USP 1-Dec-2020)

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▲25.0 83 17▲ (USP 1-Dec-2020)

Diluent▲Solvent:▲ (USP 1-Dec-2020) Alcohol and water (4:6)▲Methanol and water (7:3)
Standard solution A: 0.15 mg/mL each of USP Ginsenoside Rg1 RS and USP Ginsenoside Rb1 RS in Solvent▲ (USP 1-Dec-2020)

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Standard solution ▲B:▲ (USP 1-Dec-2020) Transfer a quantity of USP Powdered Asian Ginseng Extract RS, equivalent to 2 mg of ginsenoside Rg1,
to a suitable container, and dissolve in 10.0 mL of Diluent. [Note—The concentrations of ginsenoside Rg1 and ginsenoside Rb1 in this solution

are not expected to be equal and are determined on the basis of the labeled quantities present in USP Powdered Asian Ginseng Extract

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RS.]▲10 mg/mL of USP Powdered Asian Ginseng Extract RS in Solvent, sonicate for 10 min. Before injection, pass through a nylon filter of
0.22-µm pore size.▲ (USP 1-Dec-2020)
Sample solution: Reduce 100 g of Asian Ginseng to a powder, and transfer about 1.0 g of the powder, accurately weighed, to a 100-mL, round-
bottom flask fitted with a reflux condenser. Add 50 mL of Diluent and a few grains of pumice, and boil on a water bath under reflux for 1 h.
Cool, and filter. Wash the flask and the residue with 20 mL of Diluent, and pass through the same filter. Combine the filtrates, and evaporate in
a rotary evaporator at 50° to dryness. Dissolve the residue in 10.0 mL of Diluent.▲Transfer about 500 mg of finely powdered Asian Ginseng
Root and Rhizome, accurately weighed, into a suitable flask, add 25.0 mL of Solvent, and close tightly. Weigh the filled flask accurately, and
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sonicate for 30 min. Cool to room temperature and adjust to the initial weight by adding Solvent, if needed. Before injection, pass through a
nylon filter of 0.22-µm pore size and discard the first portion of the filtrate.▲ (USP 1-Dec-2020)
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Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 203 nm
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Column: 4.6-mm × 15-cm; 3-µm packing L1▲2.1-mm × 5-cm; 1.7-µm packing L1▲ (USP 1-Dec-2020)

Guard column: 4.6-mm × 2.0-cm; packing L1▲▲ (USP 1-Dec-2020)

Column temperature: 25°▲40°▲ (USP 1-Dec-2020)

Flow rate: 1.5▲0.8▲ (USP 1-Dec-2020) mL/min

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Injection volume: 10▲5▲ (USP 1-Dec-2020) µL

System suitability
Samples: Standard solution ▲A and Standard solution B▲ (USP 1-Dec-2020)
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Suitability requirements
▲
Resolution: NLT 1.3 between the ginsenoside Rg1 and ginsenoside Re peaks; NLT 2.5 between the ginsenoside Rb1 and chikusetsusaponin
V peaks; NLT 1.3 between the peak of ginsenoside Rd and the peak before it, Standard solution B
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Tailing factor: NMT 2.0 for ginsenoside Rg1 and ginsenoside Rb1 peaks, Standard solution A▲ (USP 1-Dec-2020)

Relative standard deviation: NMT 2.0%, determined for the sum of the peak areas for the 6 major ginsenosides, in replicate injections▲for
ginsenoside Rg1 and ginsenoside Rb1 peaks in replicate injections, Standard solution A▲ (USP 1-Dec-2020)
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Chromatogram similarity: The chromatogram ▲of Standard solution B▲ (USP 1-Dec-2020) is similar to the reference chromatogram provided
with the lot of USP Powdered Asian Ginseng Extract RS being used.
Analysis
Samples: Standard solution A, Standard solution B, and Sample solution
▲[Note—Protect from light. Standard solution A, Standard solution B, and Sample solution are stable for 24 h at room temperature.]

Using the chromatograms of Standard solution A, Standard solution B, and the reference chromatogram provided with the lot of USP
Powdered Asian Ginseng Extract RS being used, identify the peaks corresponding to ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, and Rd, and the

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peaks corresponding to chikusetsusaponin V, malonyl ginsenosides Rb1, Rc and Rb2 in the Sample solution.▲ (USP 1-Dec-2020)

Calculate the percentages of ginsenosides Rb1 and Rg1▲Separately calculate the percentages of ginsenosides Rg1, Re, and Rf against USP

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Ginsenoside Rg1 RS and the percentages of ginsenosides Rb1, Rc, Rb2, and Rd against USP Ginsenoside Rb1 RS▲ (USP 1-Dec-2020) in the

portion of Asian Ginseng ▲Root and Rhizome▲ (USP 1-Dec-2020) taken:

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Result = (rU/rS) × CS × (V/W) ▲× F▲ (USP 1-Dec-2020) × 100

rU = peak response▲area ▲
▲ (USP 1-Dec-2020) of Rg1 or ginsenoside Rb1 the relevant ginsenoside▲ (USP 1-Dec-2020) from the Sample solution

rS = peak response▲area ▲
▲ (USP 1-Dec-2020) of ginsenoside Rg1 or ginsenoside Rb1 from Standard solution A▲ (USP 1-Dec-2020)

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CS = concentration of USP Powdered Asian Ginseng Extract RS▲USP Ginsenoside Rg1 RS or USP Ginsenoside Rb1 RS
▲ (USP 1-Dec-2020) in

Standard solution ▲A▲ (USP 1-Dec-2020) (mg/mL)

V = final▲

W = weight of Asian Ginseng ▲Root and Rhizome

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▲ (USP 1-Dec-2020) volume of the Sample solution (mL)

▲ (USP 1-Dec-2020) taken to prepare the Sample solution (mg)

▲F= conversion factor for the analyte (see Table 2)

Table 2
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Conversion Factor (F) Conversion Factor (F)
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Analyte Based on Rg1 Based on Rb1

Ginsenoside Rg1 1.00 —

Ginsenoside Re 1.00 —
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Ginsenoside Rf 0.83 —

Ginsenoside Rb1 — 1.00

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Ginsenoside Rc — 0.96

Ginsenoside Rb2 — 0.96

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Ginsenoside Rd — 0.80

Calculate the content of total ginsenosides as the sum of ginsenosides Rg1, Re, Rf, Rb1, Rc, Rb2, and Rd.▲ (USP 1-Dec-2020)

Acceptance criteria
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Ginsenosides Rg1 and Re: NLT 0.2%▲0.3%▲ (USP 1-Dec-2020) on the dried basis

Ginsenoside Rb1: NLT 0.1%▲0.2%▲ (USP 1-Dec-2020) on the dried basis

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▲
Total ginsenosides: NLT 0.8% on the dried basis▲ (USP 1-Dec-2020)

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CONTAMINANTS
• Articles of Botanical Origin 〈561〉, Limits of Elemental Impurities: Meets the requirements
• Articles of Botanical Origin 〈561〉, Pesticide Residue Analysis: 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〉, Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia
coli: Meets the requirements.

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SPECIFIC TESTS
• Botanical Characteristics
Macroscopic: Fusiform or cylindrical roots, with distinct aromatic odor, sometimes branched, typically 1–10 cm, sometimes up to 20 cm in

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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 in the lower
part, with prominent horizontal rings and fine longitudinal ridges as a result of drying. Root scars or fine rootlets are present. Fractures are
short, with the fractured surface, white to ivory, exposing a ring of secretory canals present in secondary phloem.

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Microscopic: Transverse section of root presents multiple layers of thin-walled cork cells. Secondary phloem characterized by conspicuous air
lacunae, abundant starch-containing storage parenchyma, few sieve elements, and rings of schizogenous secretory canals. Xylem
characterized by abundant starch-containing storage parenchyma, few tracheary elements, and a lack of secretory canals. Druse crystals are
sometimes present with vascular parenchyma cells.
• Articles of Botanical Origin 〈561〉, Methods of Analysis, Foreign Organic Matter: NMT 2.0%
• Articles of Botanical Origin 〈561〉, Methods of Analysis, Alcohol-Soluble Extractives, Method 2: NLT 14.0%

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Add the following:
▲
• Articles of Botanical Origin 〈561〉, Methods of Analysis, Water-Soluble Extractives, Method 2: NLT 25.0%▲ (USP 1-Dec-2020)

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Change to read:

• Loss on Drying 〈731〉

Sample: 1.0 g of Asian Ginseng ▲Root and Rhizome,▲ (USP 1-Dec-2020) finely powdered
Analysis: Dry the Sample at 105° for 2 h.
Acceptance criteria: NMT 12.0%
Change to read:

• Articles of Botanical Origin 〈561〉, Methods of Analysis, Total Ash

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Sample: 1.0 g of Asian Ginseng ▲Root and Rhizome,▲ (USP 1-Dec-2020) finely powdered
Acceptance criteria: NMT 8.0%
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• Articles of Botanical Origin 〈561〉, Methods of Analysis, Acid-Insoluble Ash: NMT 1.0%

ADDITIONAL REQUIREMENTS
Change to read:

• Packaging and Storage: Preserve in well-closed containers, ▲protected from light and moisture,▲ (USP 1-Dec-2020) and store in a cool, dry place▲at
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controlled room temperature.▲ (USP 1-Dec-2020)

Change to read:

• Labeling: The label states the Latin binomial and,▲▲ (USP 1-Dec-2020) following the official name the part▲▲ (USP 1-Dec-2020) of the plant contained
in the article.
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Change to read:

• USP Reference Standards 〈11〉

USP Powdered Asian Ginseng Extract RS
▲ USP Ginsenoside Rb1 RS
USP Ginsenoside Rg1 RS▲ (USP 1-Dec-2020)
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Auxiliary Information - Please check for your question in the FAQs before contacting USP.
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Topic/Question Contact Expert Committee

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ASIAN GINSENG ROOT AND RHIZOME Cuiying Ma BDSHM2020 Botanical Dietary Supplements
Senior Scientific Liaison and Herbal Medicines

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Chromatographic Database Information: Chromatographic Database

Page Information:

Not Applicable

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