Powdered American Ginseng Extract
DEFINITION
Powdered American Ginseng Extract is prepared from the pulverized dried roots of Panax quinquefolius L. (Fam. Araliaceae), using suitable solvents, and dried to a powder. It contains NLT 10.0% of total ginsenosides, calculated on the anhydrous basis. The ratio of starting crude plant material to Powdered American Ginseng Extract is between 3:1 and 7:1.
IDENTIFICATION
• A. Thin-Layer Chromatographic Identification Test
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:
20 mg/mL in methanol
Adsorbent:
0.25-mm layer of chromatographic 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.
Spray 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
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 solvent front has moved 10.5 cm from the origin. Remove the plates, and allow to dry. Spray with Spray reagent. Heat the plates at 105–110 for 10 min, and examine.
, and develop in a chamber containing Developing solvent system B until the solvent front has moved 10.5 cm from the origin. Remove the plates, and allow to dry. Spray with Spray reagent. Heat the plates at 105–110 for 10 min, and examine.
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 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, Rc, and Rd of the Sample solution correspond to those of 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 Sample solution shows no significant 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
• 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 |
| 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:
Transfer a quantity of Powdered American Ginseng Extract, equivalent to about 5 mg of ginsenosides, to a suitable container. Dissolve in 10.0 mL of Diluent, sonicating for 10 min, and filter.
Chromatographic system
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:
Chromatogram similarity:
The chromatogram is similar to the Reference Chromatogram 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 6 major ginsenosides, in replicate injections
Analysis
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 Powdered American Ginseng Extract taken:
Result = (rU/rS) × (CS/CU) × P
| rU | = | = peak response of ginsenosides Rg1, Re, Rb1, Rc, Rb2, or Rd from the Sample solution |
| rS | = | = peak response of ginsenosides Rg1, Re, Rb1, Rc, Rb2, or Rd from the appropriate Standard solution |
| CS | = | = concentration of ginsenosides Rg1, Re, Rb1, Rc, Rb2, or Rd in the appropriate Standard solution (mg/mL) |
| CU | = | = concentration of Powdered American Ginseng Extract in the Sample solution (mg/mL) |
| P | = | = labeled amount, in percentage, of each relevant ginsenoside in USP Powdered American Ginseng Extract RS |
Calculate the percentage of total ginsenosides in the portion of Powdered American Ginseng Extract taken by adding the individual percentages.
Acceptance criteria:
NLT 10.0% of total ginsenosides on the anhydrous basis
CONTAMINANTS
• Heavy Metals, Method II 
231
:
NMT 20 ppm
231:
NMT 20 ppm
• Articles of Botanical Origin, General Method for Pesticide Residues Analysis 561:
Meets the requirements
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 103 cfu/g.
2021:
The total aerobic microbial count does not exceed 104 cfu/g. The total combined molds and yeasts count does not exceed 103 cfu/g.
• Microbiological Procedures for Absence of Specified Microorganisms 2022:
It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
2022:
It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
SPECIFIC TESTS
• Water Determination, Method I 921:
NMT 7.0%
921:
NMT 7.0%
• Botanical Extracts, Residue on Evaporation 565:
Meets the requirements
565:
Meets the requirements
• Alcohol Determination, Method II 611:
NMT 0.25%
611:
NMT 0.25%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight, light-resistant containers.
• Labeling:
The label states the Latin binomial and, following the official name, the part of the plant from which the article was derived. Label it to indicate the content of total ginsenosides, the extracting solvent used for preparation, and the ratio of the starting crude plant material to the Powdered Extract. It meets the labeling requirements under Botanical Extracts 565.
565.
• USP Reference Standards 11
11
USP Powdered American Ginseng Extract RS
USP Powdered Asian Ginseng Extract RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Maged H. Sharaf, Ph.D.
Principal Scientific Liaison 1-301-816-8318 |
(DS2010) Monographs - Dietary Supplements |
| 2021 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 2022 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1177
Pharmacopeial Forum: Volume No. 30(2) Page 564