Labeling—
Label it to indicate that it is for manufacturing purposes only, in addition to the information specified for
Labeling for
Tinctures under
Botanical Extracts 
565
.
Thin-layer chromatographic identification test 201—
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 solution only: the chromatogram obtained for the Test solution exhibits two clearly separated, intense spots from the gingerols at RF values of about 0.2 and 0.4.
Microbial enumeration 2021—
It meets the requirements of the tests for absence of
Salmonella species,
Escherichia coli, and
Staphylococcus aureus. The total aerobic microbial count does not exceed 300 cfu per g, and the total combined molds and yeasts count does not exceed 100 cfu per g.
Limit of nonvolatile residue—
Evaporate a 10-mL portion in a tared platinum or porcelain dish, and dry at 105
for 6 hours: the weight of the residue is between 80 and 120 mg.
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
rU is 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 gingerdiones test under
Ginger.
Test preparation—
Use the Tincture.
Chromatographic system
(see
Chromatography 621)—Proceed as directed for the
Content of gingerols and gingerdiones test under
Ginger, except that the relative retention times are about 0.8 for 6-gingerol, 1.0 for capsaicin, 1.64 for 8-gingerol, 2.04 for 6-shogaol, and 3.95 for 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
C is the concentration, in mg per mL, of
USP Capsaicin RS in the
Standard preparation; rU is the sum of the peak responses for gingerols obtained from the
Test preparation; and
rS is the capsaicin peak response obtained from the
Standard preparation.
Ginger