Ginger Tincture
»Prepare Ginger Tincture as follows:
Ginger 200g
Amixture of Alcohol and Water
(7:3),a sufficient quantity,
to make 1000mL
Prepare a Tincture by the Maceration Processas directed for Tincturesunder Botanical Extracts á565ñ.It contains not less than 0.10percent of gingerols.
Labeling— Label it to indicate that it is for manufacturing purposes only,in addition to the information specified for Labelingfor Tincturesunder Botanical Extracts á565ñ.
Thin-layer chromatographic identification test á201ñ—
Test solution— Use the Tincture.
Developing solvent system: a mixture of ethyl ether and solvent hexane (7:3).
Procedure— Proceed as directed in the chapter,except to use the Test solutiononly:the chromatogram obtained for the Test solutionexhibits two clearly separated,intense spots from the gingerols at RFvalues of about 0.2and 0.4.
Specific gravity á841ñ: between 0.90and 0.95.
Microbial enumeration á2021ñ— It meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.The total aerobic microbial count does not exceed 300cfu per g,and the total combined molds and yeasts count does not exceed 100cfu per g.
Total ash á561ñ: not more than 0.5%.
Pesticide residues á561ñ: meets the requirements.
Arsenic,Method IIá211ñ: not more than 1µg per g.
Limit of nonvolatile residue— Evaporate a 10-mLportion in a tared platinum or porcelain dish,and dry at 105for 6hours:the weight of the residue is between 80and 120mg.
Limit of 6-shogaol— Using the chromatograms obtained in the test for Content of gingerols,calculate the percentage of 6-shogaol in the Tincture by the formula:
0.1C(rU/rS),
in which rUis the peak response of 6-shogaol obtained from the Test preparation;and the other terms are as defined therein:not more than 0.034%is found.
Content of gingerols—
Mobile phase ,Standard preparation,and System suitability preparation—Proceed as directed for the Content of gingerols and gingerdionestest under Ginger.
Test preparation— Use the Tincture.
Chromatographic system (see Chromatography á621ñ)—Proceed as directed for the Content of gingerols and gingerdionestest under Ginger,except that the relative retention times are about 0.8for 6-gingerol,1.0for capsaicin,1.64for 8-gingerol,2.04for 6-shogaol,and 3.95for 10-gingerol;and the resolution,R,between 6-gingerol and capsaicin is not less than 5.0.
Procedure— Proceed as directed for the Content test under Ginger.Calculate the percentage of gingerols in the Tincture by the formula:
0.1C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Capsaicin RSin the Standard preparation;rUis the sum of the peak responses for gingerols obtained from the Test preparation;and rSis the capsaicin peak response obtained from the Standard preparation.
Alcohol content,Method Iá611ñ: not less than 90.0%and not more than 110.0%of the labeled amount of C2H5OHis found.
Other requirements— It meets the requirements for Packaging and Storage underBotanical Extracts á565ñ.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2093
Phone Number:1-301-816-8343