Asian Ginseng Tablets
» Asian Ginseng Tablets are prepared from Powdered Asian Ginseng Extract. They contain not less than 90.0 percent and not more than 110.0 percent of Powdered Extract, calculated as the sum of ginsenosides Rg1, Re, Rb1, Rc, Rb2, and Rd.
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 per Tablet, and the content, in mg, of ginsenosides per 100 mg of Powdered Extract.
USP Reference standards 11
USP Powdered Asian Ginseng Extract RS.
Identification
A:
Thin-Layer Chromatographic Identification Test 201
Test solution
Powder and transfer a portion of Tablets, equivalent to about 100 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 (8:2), in a 55 bath for 30 minutes, 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 (15:10).
Standard solution, Application volume, Developing solvent system, Spray reagent, and Procedure
Proceed as directed for Identification test A under Asian Ginseng.
B:
The retention times of the relevant analytes in the chromatogram of the Test solution correspond to those in the chromatogram of the Standard solution, as obtained in the test for Content of ginsenosides. The retention time of the peak for ginsenoside Rf in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the test for Content of ginsenosides.
Microbial enumeration 2021
The total aerobic microbial count does not exceed 104 cfu per g, and the total combined molds and yeasts count does not exceed 1000 cfu per g. Tablets meet the requirements of the tests for absence of Salmonella species and Escherichia coli.
Disintegration and dissolution 2040:
meet the requirements for Disintegration only; 20 minutes, the use of disks being omitted.
Weight variation 2091:
meet the requirements.
Content of ginsenosides
Solution A, Solution B, Mobile phase, and Chromatographic system
Proceed as directed for Content of ginsenosides under Powdered Asian Ginseng Extract.
Standard solution
Transfer about 200 mg of USP Powdered Asian Ginseng Extract RS, accurately weighed, to a suitable container, dissolve in 5.0 mL of a mixture of water and alcohol (6:4), and filter.
Test solution
Weigh and powder not fewer than 20 Tablets. Transfer an accurately weighed amount of the powder, equivalent to about 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 (8:2), in a 55 bath for 30 minutes, stirring with a magnetic stirrer. Evaporate the combined extracts to dryness in vacuum between 45 and 50. Dissolve the residue in 5.0 mL of a mixture of water and alcohol (6:4), and filter.
Procedure
Proceed as directed for Content of ginsenosides under Powdered Asian Ginseng Extract, except to calculate the quantity, in mg, of each relevant ginsenoside (Rg1, Re, Rb1, Rc, Rb2, and Rd) in the portion of Tablets taken by the formula:
0.05PC(rU / rS)
in which C is the concentration, in mg per mL, of USP Powdered Asian Ginseng Extract RS in the Standard solution; and the other terms are as defined therein. Calculate the quantity, in mg, of ginsenosides by adding the individual amounts calculated as above.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1028
Pharmacopeial Forum: Volume No. 30(2) Page 573
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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