Powdered Garlic Extract
»Powdered Garlic Extract is prepared from fresh Garlic bulbs by extraction with alcohol.The ratio of the starting crude plant material to Powdered Extract is between 9.5:1and 13.5:1.It contains not less than 4.0percent of alliin (C6H11NO3S).It may contain added Powdered Garlic or other suitable substances.
Packaging and storage— Preserve in tight containers,in a cool place,protected from light.
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was prepared.The label also indicates the content of alliin,the extracting solvent or solvent mixture used for preparation,and the ratio of the starting crude plant material to Powdered Extract.It meets the requirements for Labelingunder Botanical Extracts á565ñ.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Test solution— Transfer an accurately weighed quantity of Powdered Extract,equivalent to about 5mg of alliin,to a suitable container.Add 40mLof a mixture of methanol and water (1:1),and shake until the powder is fully dispersed.Centrifuge,and decant the supernatant into a round-bottom flask.Concentrate to a small volume (about 5mL)using a rotary evaporator.
Standard solution A,Standard solution B,Application volume,Developing solvent system,and Procedure— Proceed as directed for Identificationtest Aunder Garlic.
B: The retention time of the alliin peak in the chromatogram of the Test solutioncorresponds to that in the chromatogram of the Standard solution,as obtained in the test for Content of alliin.
Microbial enumeration á2021ñ— The total bacterial count does not exceed 10,000cfu per g,and the total combined molds and yeasts count does not exceed 1000cfu per g.It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Water content á561ñ: not more than 5.0%.
Content of alliin—
0.045M Phosphate buffer,0.05M Phosphate buffer,0.01M Carboxymethoxylamine hemihydrochloride solution,Derivatization reagent,Mobile phase,Standard solution,and Chromatographic system— Proceed as directed for Content of alliinunder Garlic.
Test solution— Transfer about 0.10g of Powdered Extract,accurately weighed,to a 50-mLvolumetric flask,add 30mLof 0.01M Carboxymethoxylamine hemihydrochloride solution,and shake until the Powdered Extract is fully dispersed.Dilute with 0.01M Carboxymethoxylamine hemihydrochloride solutionto volume,and mix.Centrifuge,transfer 5mLof the clear supernatant to a 10-mLvolumetric flask,dilute with 0.01M Carboxymethoxylamine hemihydrochloride solutionto volume,and mix.Using a volumetric syringe,transfer 0.1mLof this solution to a septum-capped vial,add 0.5mLof the Derivatization reagent,and mix.Allow a reaction time of not less than 2minutes before injection into the chromatograph.
Procedure— Proceed as directed for Content of alliinunder Garlic.Calculate the percentage of alliin in the portion of Powdered Extract taken by the formula:
60(C/W)(rU/rs),
in which Cis the concentration,in mg per mL,of USP Alliin RSin the Standard solution;Wis the weight,in g,of Powdered Extract taken to prepare the Test solution;and rUand rsare the sums of the peak responses for the alliin diastereomers obtained from the Test solutionand the Standard solution,respectively.
Alcohol content,Method IIá611ñ: not more than 0.5%.
Other requirements— It meets the requirements for Packaging and Storageand Pesticide Residuesunder Botanical Extracts á565ñ.
Alliinase activity—
0.045M Phosphate buffer,0.05M Phosphate buffer,0.01M Carboxymethoxylamine hemihydrochloride solution,Derivatization reagent,Mobile phase,Standard solution,and Chromatographic system— Proceed as directed for Content of alliinunder Garlic.
Test solution— Incubate 200mg of Powdered Extract with 20mLof water at room temperature for 5minutes.Immediately after incubation,add 80.0mLof 0.01M Carboxymethoxylamine hemihydrochloride solution,mix,and centrifuge.Using a volumetric syringe,transfer 0.1mLof this solution to a septum-capped vial,add 0.5mLof the Derivatization reagent,and mix.Allow a reaction time of not less than 2minutes before injection into the chromatograph.
Procedure— Proceed as directed for Content of alliinunder Garlic:the area of the alliin peak obtained from the chromatogram of the Test solutionis not more than 1%of the area of the alliin peak obtained from the chromatogram of the Standard solution.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2089
Phone Number:1-301-816-8343