Add the following:
» Curcuminoids is a partially purified natural complex of diaryl heptanoid derivatives isolated from turmeric, Curcuma longa L. It contains not less than 95.0 percent of curcuminoids, calculated on the dried basis, as the sum of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin. It contains not less than 70.0 percent and not more than 80.0 percent of curcumin, not less than 15.0 percent and not more than 25.0 percent of desmethoxycurcumin, and not less than 2.5 percent and not more than 6.5 percent of bisdesmethoxycurcumin.
Packaging and storage Preserve in well-closed containers, protected from light and moisture, and store at room temperature.
Labeling The label states the content of curcuminoids and the content of individual curcuminoids, on the dried basis; the Latin binominal; and the part of the plant used to prepare the article.
USP Reference standards 11
USP Bisdesmethoxycurcumin RS.
USP Curcumin RS.
USP Curcuminoids RS.
USP Desmethoxycurcumin RS.
A: Thin-Layer Chromatographic Identification Test 201
Test solution Dissolve about 10 mg of curcuminoids in 5 mL of acetone.
Application volume, Developing solvent system, Standard solution, 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.
Melting range, Class I 741: between 172 and 178.
Microbial enumeration 2021 The total aerobic microbial count does not exceed 104 cfu per g. The total combined yeasts and molds count does not exceed 103 cfu per g.
Absence of specified microorganisms 2022 It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on drying 731 Dry 1.0 g at 105 for 2 hours: it loses not more than 2.0% of its weight.
Total ash 561: not more than 1.0%.
Aflatoxins 561: meets the requirements.
Pesticide residues 561: meets the requirements.
Heavy metals, Method III 231: not more than 20 µg per g.
Residual solvents 467: meets the requirements.
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 20 mg of curcuminoids, 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 Curcuminoids 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 curcuminoids 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. It contains not less than 70.0% and not more than 80.0% of curcumin, not less than 15.0% and not more than 25.0% of desmethoxycurcumin, and not less than 2.5% and not more than 6.5% of bisdesmethoxycurcumin. Add the percentages due to curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin: not less than 95% is found.USP32
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 991Pharmacopeial Forum: Volume No. 33(6) Page 1215
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.