Asian Ginseng Tablets
»Asian Ginseng Tablets are prepared from Powdered Asian Ginseng Extract.They contain not less than 90.0percent and not more than 110.0percent 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 100mg of Powdered Extract.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Test solution— Powder and transfer a portion of Tablets,equivalent to about 100mg of Powdered Extract,to a conical flask,and extract three times,each with a 20-mLportion of a mixture of methanol and water (8:2),in a 55bath for 30minutes,stirring with a magnetic stirrer.Evaporate the combined extracts to dryness in vacuum between 45and 50,and dissolve the residue in 10mLof a mixture of methanol and water (15:10).
Standard solution,Application volume,Developing solvent system,Spray reagent,and Procedure— Proceed as directed for Identificationtest Aunder Asian Ginseng.
B: The retention times of the relevant analytes in the chromatogram of the Test solutioncorrespond 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 solutioncorresponds to that in the chromatogram of the Standard solution,as obtained in the test for Content of ginsenosides.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 104cfu per g,and the total combined molds and yeasts count does not exceed 1000cfu per g.Tablets meet the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Disintegration and dissolution á2040ñ: meet the requirements for Disintegrationonly;20minutes,the use of disks being omitted.
Weight variation á2091ñ: meet the requirements.
Change to read:
Content of ginsenosides—
Solution A,Solution B,Mobile phase,and Chromatographic system— Proceed as directed for Content of ginsenosidesunder Powdered Asian Ginseng Extract.
Standard solution— Transfer about 200mg of USP Powdered Asian Ginseng Extract RS,accurately weighed,to a suitable container,dissolve in 5.0mLof a mixture of water and alcohol (6:4),and filter.USP28
Test solution— Weigh and powder not fewer than 20Tablets.Transfer an accurately weighed amount of the powder,equivalent to about 200mg of Powdered Extract,to a conical flask,and extract three times,each with a 20-mLportion of a mixture of methanol and water (8:2),in a 55bath for 30minutes,stirring with a magnetic stirrer.Evaporate the combined extracts to dryness in vacuum between 45and 50.Dissolve the residue in 5.0mLof a mixture of water and alcohol (6:4),and filter.USP28
Procedure— Proceed as directed for Content of ginsenosidesunder 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 Cis the concentration,in mg per mL,of USP Powdered Asian Ginseng Extract RSin 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— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2100
Pharmacopeial Forum:Volume No.30(2)Page 573
Phone Number:1-301-816-8343