» Prepare Ginger Tincture as follows:
Prepare a Tincture by the Maceration Process as directed for Tinctures under Botanical Extracts 565. It contains not less than 0.10 percent of gingerols.
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 hexanes (7:3).
Procedure Proceed as directed in Identification test C under Ginger.
Specific gravity 841: between 0.90 and 0.95.
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 103 cfu per g.
Total ash 561: not more than 0.5%.
Pesticide residues 561: meets the requirements.
Arsenic, Method II 211: not more than 1 µg per g.
Heavy metals, Method III 231: 0.001%.
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, System suitability solution, and Chromatographic system Proceed as directed for the Content of gingerols and gingerdiones test under Ginger.
Test preparation Use the Tincture.
Procedure Proceed as directed for the Content of gingerols and gingerdiones 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.
Alcohol content, Method I 611: not less than 90.0% and not more than 110.0% of the labeled amount of C2H5OH is found.
Other requirements It meets the requirements for Packaging and Storage under Botanical Extracts 565.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1017Pharmacopeial Forum: Volume No. 32(1) Page 163