Asian Ginseng Tablets
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.
• 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 µL, as bands
Developing solvent system: The upper layer of a mixture 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 glacial acetic acid. Add 85 mL of methanol, carefully add 5 mL of sulfuric acid, and mix.
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 corresponding 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 the same RF value as the gray zone corresponding to escin in the chromatogram of 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.
• B. The retention times of the relevant analytes of the Sample solution correspond to those of the Standard solution, as obtained in the test for Content of Ginsenosides. The retention time of the peak for ginsenoside Rf of the Sample solution corresponds to that of the Standard solution, as obtained in the test for Content of Ginsenosides.
• Content of Ginsenosides
Diluent: Water and alcohol (3:2)
Solution A: Water
Solution B: Acetonitrile and water (4:1)
Mobile phase: See the gradient table below.
Standard solution: 40 mg/mL of USP Powdered Asian Ginseng Extract RS in Diluent. Filter.
Sample solution: Weigh and finely powder NLT 20 Tablets. 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.
Detector: UV 203 nm
Guard: 4.6-mm × 2.0-cm; packing L1
Analytical: 4.6-mm × 15-cm; 3-µm packing L1
Column temperature: 25
Flow rate: 1.5 mL/min
Injection size: 20 µL
Sample: Standard solution
Chromatogram similarity: The Standard solution 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 six major ginsenosides, in repeated injections
Samples: Standard solution and Sample solution
Record the chromatograms, identify the peaks for the ginsenosides by comparison with the Reference Chromatogram 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 ginsenoside (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of Tablets taken:
Result = 0.05 × (rU/rS) × CS × P
Calculate the content of total ginsenosides, T, in mg, by adding the amounts of individual ginsenoside.
Calculate the percentage of Powdered Extract with respect to the label claim:
Result = T × (AWT/W) × (100/LE) × (100/L)
Acceptance criteria: 90.0%110.0% of Powdered Extract, calculated as the sum of ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd
• Disintegration and Dissolution of Dietary Supplements 2040: Meet the requirements for Disintegration
• Weight Variation of Dietary Supplements 2091: Meet the requirements
• Microbial Enumeration Tests 2021: The total aerobic microbial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does not exceed 1000 cfu/g. Tablets meet the requirements of the tests for absence of Salmonella species and Escherichia coli.
• Packaging and Storage: Preserve in tight containers, protected from light.
• Labeling: The label states the Latin binomial and, following the official name, the article from which the Tablets were prepared. The label also indicates the amount of Powdered Extract, in mg/Tablet, and the content, in mg, of ginsenosides per 100 mg of Powdered Extract.
• USP Reference Standards 11
USP Powdered Asian Ginseng Extract RS
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USP35NF30 Page 1186Pharmacopeial Forum: Volume No. 36(1) Page 160