Powdered Asian Ginseng Extract
Powdered Asian Ginseng Extract is prepared from Asian Ginseng by maceration, percolation, or both processes performed at room temperature with suitable solvents such as alcohol, methanol, water, or mixtures of these solvents, and by concentrating the fluidextract at temperatures below 50. The ratio of the starting crude plant material to Powdered Asian Ginseng Extract is between 3:1 and 7:1. It contains NLT 3.0% of ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd combined, calculated on the anhydrous basis. It may contain other added substances.
• A. Thin-Layer Chromatographic Identification Test
Extraction column: Use a solid-phase extraction column that contains C18 packing with 55- to 105-µm particle size and a ratio of sorbent mass to column volume of 360 mg/0.85 mL, or equivalent. Condition the column before use by washing with 3 mL of methanol and 8 mL of water.
Standard solution: Transfer about 0.1 g of USP Powdered Asian Ginseng Extract RS to a 5-mL volumetric flask, and proceed as directed for the Sample solution, beginning with Dissolve in water.
Sample solution: About 1.0 g of Powdered Asian Ginseng Extract in a 25-mL volumetric flask. Dissolve in water, sonicating if necessary. Dilute with water to volume. Transfer 4.0 mL of this solution to the Extraction column, wash with 10 mL of water, and discard the eluate. Elute the column with 2 mL of methanol. [NoteDo not use vacuum, elute manually and slowly. ] Collect the eluate in a suitable vial.
Adsorbent: 0.2-mm layer of chromatographic silica gel mixture on a high-performance thin-layer plate
Application volume: 10 µL, as bands
Developing solvent system: Chloroform, methanol, and water (65:35:10). Use the lower phase.
Spray reagent: Alcohol, acetic anhydride, and sulfuric acid (18:1:1)
Samples: Standard solution and Sample solution
Saturate the chamber with Developing solvent system for 2 h. 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, and heat in an oven at 105 for 10 min. Immediately examine the plate in white light.
Acceptance criteria: The Sample solution exhibits, among other spots, eight brown-violet spots at the RF 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 obtained for the Standard solution.
• B. Add 2 mL of glacial acetic acid to 0.1 g of Powdered Asian Ginseng Extract, warm for 5 min in a hot water bath, and filter. Gently add 0.5 mL of sulfuric acid to 1.0 mL of the filtrate.
Acceptance criteria: A red-brown color develops at the zone of contact.
• C. The retention times of the peaks for ginsenosides Rg1, Re, Rf, Rb1, Rb2, Rc, and Rd in the Sample solution chromatogram correspond to those in the Standard solution, as obtained in the test for Content of Ginsenosides. The ratio of the peak area of Rb2 to the peak area of Rb1 is NLT 0.4 (differentiation from American Ginseng).
• Content of Ginsenosides
Solution A: Water
Solution B: Acetonitrile and water (4:1)
Mobile phase: See Table 1.
Diluent: Alcohol and water (4:6)
Standard solution: 24 mg/mL of USP Powdered Asian Ginseng Extract RS in Diluent. Dissolve by sonicating for 10 min, mix, and filter.
Sample solution: Proceed as directed for Standard solution, except use Powdered Asian Ginseng Extract.
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: 20 µL
Sample: Standard solution
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
Samples: Standard solution and Sample solution
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 6 major ginsenosides.
Calculate the percentage of each relevant ginsenoside (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of Powdered Asian Ginseng Extract taken:
Result = (rU/rS) × (CS/CU) × P
Calculate the percentage of ginsenosides by adding the percentages of each relevant ginsenoside.
Acceptance criteria: NLT 3.0% on the anhydrous basis
• Heavy Metals 231: NMT 30 ppm
• Articles of Botanical Origin, General Method for Pesticide Residues Analysis 561: Meets the requirements
• Microbial Enumeration Tests 2021: The total aerobic microbial count does not exceed 300 cfu/g. The total combined molds and yeasts count does not exceed 100 cfu/g.
• Microbiological Procedures for Absence of Specified Microorganisms2022: It meets the requirements of the tests for absence of Salmonella species, Escherichia coli, and Staphylococcus aureus.
• Water Determination, Method I 921: NMT 7.0%, determined on a 0.15-g specimen
• Alcohol Determination, Method II 611: NMT 0.25%
• Packaging and Storage: Meets the requirements in Botanical Extracts 565
• Labeling: Meets the requirements in Botanical Extracts 565
• USP Reference Standards 11
USP Powdered Asian Ginseng Extract RS
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