American Ginseng Tablets
American Ginseng Tablets contain Powdered American Ginseng Extract. Tablets contain NLT 90.0% and NMT 110.0% of Extract, calculated as the sum of ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd.
• A. Thin-Layer Chromatographic Identification Test 201
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 a quantity of finely powdered Tablets, equivalent to 100 mg of Extract, to a conical flask. Extract at 55 with three 20-mL portions of a mixture of methanol and water (2:8). Evaporate the combined extracts to dryness under vacuum at 4550. Dissolve the residue in 5 mL of methanol.
Application volume: 20 µL
Developing solvent system A: The lower phase of a mixture of chloroform, methanol, and water (13:7:2)
Developing solvent system B: The upper phase of a mixture of butyl alcohol, ethyl acetate, and water (4:1:5)
Spray reagent: Dissolve 0.5 mL of anisaldehyde in 10 mL of glacial acetic acid, add 85 mL of methanol, mix, carefully add 5 mL of sulfuric acid, and mix.
Samples: Standard solution A, Standard solution B, and Sample solution
Proceed as directed in the chapter. Develop in a chamber containing Developing solvent system A until the solvent front has moved 10.5 cm from the origin. Remove the plates from the chamber, 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 from the chamber, and allow to dry. Spray with Spray reagent. Heat the plates at 105110 for 10 min, and examine. The order, from top to bottom, of ginsenosides on the 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
Acceptance criteria: The chromatogram of Standard solution A does not exhibit a spot for ginsenoside Rf. Standard solution B exhibits a spot for ginsenoside Rf. 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 in the chromatogram of the Sample solution correspond to those from the Standard solution, as obtained in the test for Content of Ginsenosides. The ratio of the peak response for Rb2 to the peak response for Rb1 is less than 0.4; and the ratio of the peak response for Rg1 to the peak response for Rb1 is less than 0.3. The Sample solution chromatogram shows no significant peak at the retention time corresponding to that of ginsenoside Rf in the System suitability 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: A solution of USP Powdered American Ginseng Extract RS in Diluent containing the equivalent of 1 mg/mL of ginsenoside Rb1
Sample solution: Accurately weigh and finely powder NLT 20 Tablets. Transfer to a conical flask an accurately weighed portion of the powder expected to contain an amount of Extract equivalent to 15 mg of total ginsenosides, add 15 mL of methanol, and shake to mix. Sonicate the mixture at 2530 for 30 min. Cool, pass through filter paper, and return the residue to the conical flask. Add another 15 mL of methanol, sonicate the mixture at 2530 for 30 min, and filter. Wash the residue with three 15-mL portions of methanol. Evaporate the combined extracts and washings to dryness under vacuum at 4550. Transfer the residue to a 10.0-mL volumetric flask, using small volumes of methanol, and dilute with methanol to volume.
System suitability solution: 24 mg/mL of USP Powdered Asian Ginseng Extract RS in Diluent. Filter.
Detector: UV 203 nm
Guard column: 4.6-mm × 2.0-cm; packing L1
Analytical column: 4.6-mm × 15-cm; 3-µm packing L1
Column temperature: 25
Flow rate: 1.5 mL/min
Injection size: 10 µL
Sample: System suitability solution (inject 20 µL)
Chromatogram similarity: The System suitability 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
Identify ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd in the Standard solution and Sample solution by comparing the chromatograms with the Reference Chromatogram provided with USP Powdered American Ginseng Extract RS lot being used, and measure the peak responses.
Calculate the quantity, in mg, of each relevant ginsenoside (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of Tablets taken:
Result = 0.1 × (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 TestsNutritional and Dietary Supplements 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. Meet the requirements of the tests for absence of Salmonella species and Escherichia coli.
• Packaging and Storage: Preserve in tight containers, protected from light. Store at controlled room temperature.
• 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 Extract, in mg/Tablet. Label the Tablets to indicate the percentage of total ginsenosides in the Extract contained in the Tablets.
• USP Reference Standards 11
USP Powdered American Ginseng Extract RS
USP Powdered Asian Ginseng Extract RS
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USP35NF30 Page 1181Pharmacopeial Forum: Volume No. 36(1) Page 159