Accessed from 128.83.63.

20 by nEwp0rt1 on Wed Nov 30 20:44:42 EST 2011

USP 35 Dietary Supplements / Asian Ginseng 1185

USP REFERENCE STANDARDS 11 ratio of the peak area of Rb2 to the peak area of Rb1 is
USP Powdered Asian Ginseng Extract RS NLT 0.4 (differentiation from American Ginseng).
COMPOSITION
CONTENT OF GINSENOSIDES
.

Solution A: Water
Powdered Asian Ginseng Extract Solution B: Acetonitrile and water (4:1)
Mobile phase: See Table 1.
DEFINITION
Powdered Asian Ginseng Extract is prepared from Asian Gin- Table 1
seng by maceration, percolation, or both processes per- Time Solution A Solution B
formed at room temperature with suitable solvents such (min) (%) (%)
as alcohol, methanol, water, or mixtures of these solvents, 0 76 24
and by concentrating the fluidextract at temperatures be-
low 50. The ratio of the starting crude plant material to 12 76 24
Powdered Asian Ginseng Extract is between 3:1 and 7:1. 28 65 35
It contains NLT 3.0% of ginsenosides Rg1, Re, Rb1, Rc, 51.5 56.5 43.5
Rb2, and Rd combined, calculated on the anhydrous basis. 52.5 0 100
It may contain other added substances. 64.5 76 24
IDENTIFICATION 77 76 24
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
Extraction column: Use a solid-phase extraction column Diluent: Alcohol and water (4:6)
that contains C18 packing with 55- to 105-m particle Standard solution: 24 mg/mL of USP Powdered Asian
size and a ratio of sorbent mass to column volume of Ginseng Extract RS in Diluent. Dissolve by sonicating for
360 mg/0.85 mL, or equivalent. Condition the column 10 min, mix, and filter.
before use by washing with 3 mL of methanol and 8 mL Sample solution: Proceed as directed for Standard solu-
of water. tion, except use Powdered Asian Ginseng Extract.
Standard solution: Transfer about 0.1 g of USP Pow- Chromatographic system
dered Asian Ginseng Extract RS to a 5-mL volumetric (See Chromatography 621, System Suitability.)
flask, and proceed as directed for the Sample solution, Mode: LC
beginning with Dissolve in water. Detector: UV 203 nm
Sample solution: About 1.0 g of Powdered Asian Gin- Analytical column: 4.6-mm 15-cm; 3-m packing L1
seng Extract in a 25-mL volumetric flask. Dissolve in Guard column: 4.6-mm 2.0-cm; packing L1
water, sonicating if necessary. Dilute with water to vol- Column temperature: 25
ume. Transfer 4.0 mL of this solution to the Extraction Flow rate: 1.5 mL/min
column, wash with 10 mL of water, and discard the elu- Injection size: 20 L
ate. Elute the column with 2 mL of methanol. [NOTE System suitability
Do not use vacuum, elute manually and slowly.] Collect Sample: Standard solution
the eluate in a suitable vial. Suitability requirements
Adsorbent: 0.2-mm layer of chromatographic silica gel Chromatogram similarity: The chromatogram is sim-
mixture on a high-performance thin-layer plate ilar to the Reference Chromatogram provided with
Application volume: 10 L, as bands the lot of USP Powdered Asian Ginseng Extract RS
Developing solvent system: Chloroform, methanol, and being used.
water (65:35:10). Use the lower phase. Relative standard deviation: NMT 2.0%, determined
Spray reagent: Alcohol, acetic anhydride, and sulfuric for the sum of the peak areas for the 6 major ginse-
acid (18:1:1) nosides, in replicate injections
Analysis Analysis
Samples: Standard solution and Sample solution Samples: Standard solution and Sample solution
Saturate the chamber with Developing solvent system for Identify the peaks for the ginsenosides by comparison
2 h. Develop the chromatograms until the solvent front with the Reference Chromatogram provided with the
has moved up about three-fourths of the length of the lot of USP Powdered Asian Ginseng Extract RS being
plate. Remove the plate from the chamber, mark the used, and measure the peak areas for the 6 major
solvent front, and allow the plate to dry. Spray with ginsenosides.
Spray reagent, and heat in an oven at 105 for 10 min. Calculate the percentage of each relevant ginsenoside
Immediately examine the plate in white light. (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of Pow-
Acceptance criteria: The Sample solution exhibits, dered Asian Ginseng Extract taken:
among other spots, eight brown-violet spots at the RF Result = (rU/rS) (CS/CU) P
values of about 0.70, 0.60, 0.50, 0.36, 0.30, 0.28, 0.20,
and 0.18, corresponding in color and RF values to those rU = peak area for each relevant ginsenoside from
obtained for the Standard solution. the Sample solution
B. Add 2 mL of glacial acetic acid to 0.1 g of Powdered rS = peak area for each relevant ginsenoside from
Asian Ginseng Extract, warm for 5 min in a hot water the Standard solution
bath, and filter. Gently add 0.5 mL of sulfuric acid to 1.0 CS = concentration of USP Powdered Asian Ginseng
mL of the filtrate. Extract RS in the Standard solution (mg/mL)
Acceptance criteria: A red-brown color develops at the CU = concentration of Powdered Asian Ginseng
zone of contact. Extract in the Sample solution (mg/mL)
C. The retention times of the peaks for ginsenosides Rg1, P = labeled amount, in percentage, of each
Re, Rf, Rb1, Rb2, Rc, and Rd in the Sample solution chro- relevant ginsenoside in the USP Powdered
matogram correspond to those in the Standard solution, Asian Ginseng Extract RS
as obtained in the test for Content of Ginsenosides. The

Official from May 1, 2012

Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.
 Accessed from 128.83.63.20 by nEwp0rt1 on Wed Nov 30 20:44:42 EST 2011

1186 Asian Ginseng / Dietary Supplements USP 35

Calculate the percentage of ginsenosides by adding the the same RF value as the gray zone corresponding to
percentages of each relevant ginsenoside. escin in the chromatogram of the Standard solution.
Acceptance criteria: NLT 3.0% on the anhydrous basis Other, less intense bands may be observed between the
zones due to ginsenosides Rb1 and Re, and the zone
CONTAMINANTS closest to the origin corresponds to ginsenoside Rc.
HEAVY METALS 231: NMT 30 ppm Other spots may be visible in the lower third of the
ARTICLES OF BOTANICAL ORIGIN, General Method for chromatogram.
Pesticide Residues Analysis 561: Meets the requirements B. The retention times of the relevant analytes of the
MICROBIAL ENUMERATION TESTS 2021: The total aerobic Sample solution correspond to those of the Standard solu-
microbial count does not exceed 300 cfu/g. The total tion, as obtained in the test for Content of Ginsenosides.
combined molds and yeasts count does not exceed 100 The retention time of the peak for ginsenoside Rf of the
cfu/g. Sample solution corresponds to that of the Standard solu-
MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED tion, as obtained in the test for Content of Ginsenosides.
MICROORGANISMS2022: It meets the requirements of
the tests for absence of Salmonella species, Escherichia STRENGTH
coli, and Staphylococcus aureus. CONTENT OF GINSENOSIDES
Diluent: Water and alcohol (3:2)
SPECIFIC TESTS Solution A: Water
WATER DETERMINATION, Method I 921: NMT 7.0%, Solution B: Acetonitrile and water (4:1)
determined on a 0.15-g specimen Mobile phase: See the gradient table below.
ALCOHOL DETERMINATION, Method II 611: NMT 0.25%
ADDITIONAL REQUIREMENTS Time Solution A Solution B
PACKAGING AND STORAGE: Meets the requirements in (min) (%) (%)
Botanical Extracts 565 0 76 24
LABELING: Meets the requirements in Botanical Extracts 12 76 24
565 28 65 35
USP REFERENCE STANDARDS 11 51.5 56.5 43.5
USP Powdered Asian Ginseng Extract RS
52.5 0 100
64.5 76 24
77 76 24
.

Asian Ginseng Tablets Standard solution: 40 mg/mL of USP Powdered Asian

DEFINITION
Asian Ginseng Tablets are prepared from Powdered Asian
Ginseng Extract. They contain NLT 90.0% and NMT
110.0% of Powdered Extract, calculated as the sum of
ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd.
IDENTIFICATION
A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
201
Standard solution: 5 mg/mL each of arbutin and escin,
in methanol
Sample solution: Transfer the equivalent of 100 mg of
Powdered Extract from powdered Tablets to a conical
flask, and extract three times, each with a 20-mL portion
of a mixture of methanol and water (4:1), in a 55 bath
for 30 min, stirring with a magnetic stirrer. Evaporate the
combined extracts to dryness in vacuum between 45
and 50, and dissolve the residue in 10 mL of a mixture
of methanol and water (3:2).
Application volume: 20 L, as bands
Developing solvent system: The upper layer of a mix-
ture of butyl alcohol, ethyl acetate, and water (4:1:2) in
an unsaturated chamber
Spray reagent: 0.5 mL of anisaldehyde in 10 mL of gla-
cial acetic acid. Add 85 mL of methanol, carefully add 5
mL of sulfuric acid, and mix.
Analysis
Samples: Standard solution and Sample solution
Proceed as directed in the chapter. Remove the plate
from the developing chamber, and allow it to dry.
Spray with Spray reagent. Heat the plate at 105110
for 10 min, and examine the plate.
Acceptance criteria: The chromatogram of the Standard
solution shows, in the upper third, a brown zone corre-
sponding to arbutin and, in the lower third, a gray zone
corresponding to escin. Between these two zones, the
chromatogram of the Sample solution exhibits violet-gray
zones corresponding to ginsenoside Rg1 in the upper
portion and to ginsenoside Re in the middle. A violet-
gray zone corresponding to ginsenoside Rb1 is located at
Ginseng Extract RS in Diluent. Filter.
Sample solution: Weigh and finely powder NLT 20 Tab-
lets. Transfer a quantity of the powder, equivalent to 200
mg of Powdered Extract to a conical flask, and extract
three times, each with a 20-mL portion of a mixture of
methanol and water (4:1), in a 55 bath for 30 min,
stirring with a magnetic stirrer. Evaporate the combined
extracts to dryness in a vacuum between 45 and 50.
Dissolve the residue in 5.0 mL of Diluent, and filter.
Chromatographic system
(See Chromatography 621, System Suitability.)
Mode: LC
Detector: UV 203 nm
Column
Guard: 4.6-mm 2.0-cm; packing L1
Analytical: 4.6-mm 15-cm; 3-m packing L1
Column temperature: 25
Flow rate: 1.5 mL/min
Injection size: 20 L
System suitability
Sample: Standard solution
Suitability requirements
Chromatogram similarity: The Standard solution
chromatogram is similar to the Reference Chromato-
gram provided with the lot of USP Powdered Asian
Ginseng Extract RS being used.
Relative standard deviation: NMT 2.0%, determined
for the sum of the peak areas for the six major ginse-
nosides, in repeated injections
Analysis
Samples: Standard solution and Sample solution
Record the chromatograms, identify the peaks for the
ginsenosides by comparison with the Reference Chro-
matogram provided with the lot of USP Powdered
Asian Ginseng Extract RS being used, and measure the
peak areas for the six major ginsenosides.
Calculate the quantity, in mg, of each relevant ginseno-
side (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of
Tablets taken:
Result = 0.05 (rU/rS) CS P

Official from May 1, 2012

Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.