สารบัญ

          Turmeric Dry Extract Capsules contain an amount of Turmeric Dry Extract equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of curcuminoids, calculated as curcumin (C₂₁H₂₀O₆) and on the dried basis.

Strength available 250 mg (equivalent to curcuminoids).

Dose Two capsules three times a day after meals.

Warning

          1. Long-term use is not recommended in pregnant or nursing women.

          2. Use in patients with bile duct obstruction is not recommended, except under medical supervision.

          3. Caution should be exercised when it is to be used concomitantly with anticoagulants and antiplatelets.

Packaging and storage Turmeric Dry Extract Capsules shall be kept in tightly closed containers, protected from light, and stored in a dry place and at a temperature not exceeding 30°.

Labelling The label on the container states (1) the equivalent amount of curcuminoids as curcumin; (2) the expiration date.

Identification The capsule contents comply with the tests for Identification described under Turmeric Dry Extract.

Loss on drying Not more than 7.0 per cent w/w after drying at 105° for 2 hours (Appendix 4.15). Use 1.0 g.

Microbial limit Comply with the requirements for Category 1A in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay Carry out the determination as described in the “Ultraviolet and Visible Spectrophotometry” (Appendix 2.2).

          Standard curcumin solution Dissolve an accurately weighed quantity of Curcumin RS in methanol. Dilute quantitatively and stepwise with methanol to obtain a solution having a known concentration of about 30 μg of curcumin per mL.

          Standard curcumin curve Transfer into five 50-mL volumetric flasks, 2.0, 3.0, 4.0, 5.0 and 6.0 mL of Standard curcumin solution, dilute to volume with methanol, and mix. Measure the absorbances of the standard solutions at the maximum at about 420 nm, using methanol as the blank (Appendix 2.2). Plot the readings and draw the curve of best fit: the curve shows the correlation coefficient of not less than 0.995.

          Assay preparation Weigh and mix the contents of not less than 20 Turmeric Dry Extract Capsules. Transfer an accurately weighed portion of the capsule contents, containing about 50 mg of curcuminoids, to a 100-mL volumetric flask, add 70 mL of methanol and sonicate for 15 minutes. Adjust to volume with methanol. Dilute quantitatively with methanol to obtain a solution containing 2.5 μg of curcumin per mL. Prepare three replicate samples for each analysis: the relative standard deviation is not more than 2.0 per cent.

          Procedure and Calculation Measure the absorbance of Assay preparation at the maximum at about 420 nm, using methanol as the blank. By reference to the Standard curcumin curve, calculate the content of curcuminoids as curcumin, C₂₁H₂₀O₆, in the portion of the Capsules taken.

Other requirements Comply with the requirements described under “Capsules” (Appendix 1.16H).