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Add the following:
» Powdered Turmeric Extract is prepared from the pulverized rhizomes of Curcuma longa L. (Fam. Zingiberaceae), using acetone, methanol, or other suitable solvents. It contains not less than 20 percent of total curcuminoids, calculated on the dried basis. It may contain other added substances.
Packaging and storage
Preserve in well-closed containers, protected from light and moisture, and store at controlled room temperature.
Labeling
The label states the Latin binominal and, following the official name, the part of the plant contained in the article. It meets other labeling requirements under Botanical Extracts
USP Reference standards
USP Bisdesmethoxycurcumin RS. USP Curcumin RS. USP Curcuminoids RS. USP Desmethoxycurcumin RS.
Identification
A:
Thin-Layer Chromatographic Identification Test
Test solution:
10 mg per mL of Extract in acetone.
Standard solution, Application volume, Developing solvent system, and Procedure
Proceed as directed for Identification test A under Turmeric.
B:
The retention times of the peaks for curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin in the chromatogram of the Test solution correspond to those in the chromatogram of the Standard solution for the appropriate USP Reference Standard, as obtained in the test for Content of curcuminoids.
Microbial enumeration
Absence of specified microorganisms
Loss on drying
Aflatoxins
Pesticide residues
Heavy metals, Method III
Content of curcuminoids
Mobile phase, Standard solution 1, Standard solution 2, Standard solution 3, Standard solution 4, and Chromatographic system
Proceed as directed in the test for Content of curcuminoids under Turmeric.
Test solution
Transfer about 100 mg of Extract, accurately weighed, to a 50-mL volumetric flask, add about 30 mL of acetone, and sonicate for 30 minutes. Dilute with acetone to volume, mix, and centrifuge. Transfer 5 mL of the supernatant to a 50-mL volumetric flask, dilute with Mobile phase to volume, mix, and before injection pass through a filter having a 0.45-µm porosity.
Procedure
Proceed as directed in the test for Content of curcuminoids under Turmeric. Separately calculate the percentages of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin in the portion of Extract taken by the formula:
50,000(C / W)(rU / rS)
in which C is the concentration, in mg per mL, of USP Curcumin RS, USP Desmethoxycurcumin RS, or USP Bisdesmethoxycurcumin RS in the corresponding Standard solution; W is the weight, in mg, of Extract taken to prepare the Test solution; rU is the peak response of the relevant analyte in the Test solution; and rS is the peak response of the relevant analyte in the corresponding Standard solution. Add the percentages due to curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin: not less than 20% is found.
Other requirements
It meets the requirements of the test for Residual Solvents under Botanical Extracts
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1079
Pharmacopeial Forum: Volume No. 33(6) Page 1232
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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