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     Five-Leaf Ginseng Dry Extract is prepared from the powdered Five-Leaf Ginseng by extraction with water. It contains not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of total crude saponins; the labelled amount of total crude saponins is not less than 15.0 per cent, calculated on the dried basis. It may contains other added substances.

Description  Yellowish green fine powder; odour, characteristic.

Packaging and storage  Five-Leaf Ginseng Dry Extract shall be kept in well-closed containers, protected from light, and stored in a cool and dry place.

Labelling The label on the container states (1) the amount of total crude saponins; (2) the expiration date.

Identification

     A. To 200 mg of the sample, in powder, add 10 mL of water and heat on a water-bath for 15 minutes (solution 1). Transfer solution 1 to a separator and extract with the equal volume of 1-butanol. To the 1-butanol extract, add 100 mg of decolorizing charcoal, swirl for a few minutes and filter.  Evaporate 2 mL of the filtrate to dryness and add a few drops of sulfuric acid: a red colour is produced.

     B.  Transfer 1 mL of solution 1 to a stoppered test-tube and shake for about 15 seconds: a persistent foam is produced for over 30 minutes.

     C. Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1), using silica gel G as the coating substance and a lower layer of a mixture of 65 volumes of chloroform, 35 volumes of methanol and 10 volumes of water as the mobile phase and allowing the solvent front to ascend 10 cm above the line of application. Apply separately to the plate, 5 μL each of the following two solutions.  For solution (A), transfer 500 mg of the sample, in powder, to a 100-mL volumetric flask, dissolve in 50 mL of water, mix and adjust to volume.  Transfer 10 mL of the solution to a separator, add 15 mL of water and extract the mixture with three 15-mL portions of 1-butanol. Evaporate the combined 1-butanol extract to dryness. Dissolve the residue in 1 mL of methanol. For solution (B), dissolve 1 mg of gypenoside III in 1 mL of methanol. After removal of the plate, allow it to dry in air. Spray the plate with a 20 per cent v/v solution of sulfuric acid in methanol and heat at 105° for 5 minutes. The chromatogram obtained from solution (A) shows a violet spot corresponding to the gypenoside III spot obtained from solution (B).  Several spots of different colours appear.

Loss on drying  Not more than 9.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15).

Assay Transfer about 400 mg of Five-Leaf Ginseng Dry Extract, in powder, accurately weighed, to a 100-mL volumetric flask, add 50 mL of water, mix, and adjust to volume.  Transfer 10.0 mL of this solution to a separator and extract with three 15-mL portions of 1-butanol.  Combine the 1-butanol extracts, wash with two 10-mL portions of water and discard the washings.  Evaporate the combined 1-butanol extract to dryness and dry the residue at 105° to constant weight.  Weigh the residue and calculate the content of total crude saponins on the dried basis.

Other requirements  Complies with the requirements described under “Extracts” (Appendix 1.16H).