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.
Identification
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 10
4 cfu per g. The total combined yeast and mold count does not exceed 10
3 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.
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