Add the following:
» Curcuminoids Tablets are prepared from Curcuminoids and contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of curcuminoids, calculated as the sum of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin.
Packaging and storage Preserve in well-closed containers, protected from light and moisture, and store at room temperature.
Labeling The label indicates the content of curcuminoids in mg per Tablet.
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 Grind not fewer than 20 Tablets, and transfer a portion of the powder, equivalent to about 10 mg of curcuminoids, to a suitable container, add 5 mL of acetone, shake for 1 minute, and sonicate for 10 minutes. Allow to stand for 15 minutes before use.
Adsorbent, Application volume, Developing solvent system, Standard solution, and ProcedureProceed 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 2021 The total aerobic microbial count does not exceed 104 cfu per g. The total combined yeast and mold count does not exceed 103 cfu per g.
Absence of specified microorganisms 2022 Tablets meet the requirements of the tests for absence of Salmonella species and Escherichia coli.
Disintegration and dissolution 2040: meet the requirement for Dissolution.
Medium: water containing 1% sodium lauryl sulfate; 900 mL.
Apparatus 2: 100 rpm.
Time: 60 minutes.
Test solution Combine 25-mL portions of the solution under test from each of the six dissolution vessels, and mix. Transfer 5-mL of the resulting solution, accurately measured, to a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Determine the amount of curcumin dissolved by employing the method used in the test for Content of curcuminoids, making any necessary modifications.
Tolerances Not less than 75% of the content of curcumin is dissolved in 60 minutes.
Weight variation 2091 : meet 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 Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed quantity of the powder, equivalent to about 20 mg of curcuminoids, to a 50-mL volumetric flask, add about 30 mL of acetone, sonicate for 30 minutes, dilute with acetone to volume, mix, and centrifuge. Transfer 5 mL 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 amount, in mg, of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin in the portion of the Tablets taken by the formula:
500C(rU / rS)in which C, rU, and rS are as defined therein. Calculate the content of curcuminoids, in mg, in the portion of Tablets taken by adding the amounts of curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin.USP32
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 992Pharmacopeial Forum: Volume No. 33(6) Page 1218
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.