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          Turmeric Capsules contain an amount of powdered Turmeric equivalent to not less than 80.0 per cent of the labelled amount of volatile oil and not less than 90.0 per cent of the labelled amount of curcuminoids, calculated as curcumin (C₂₁H₂₀O₆).

Strength available 250 mg (powder).

Dose Two to four capsules four times a day after meals and at bedtime.

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 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 volatile oil and curcuminoids as curcumin; (2) the expiration date.

Identification

          A. The capsule contents exhibit diagnostic structures of the powdered drug described under Turmeric

          B. The capsule contents comply with the tests for Identification A and B described under Turmeric.

Water Of the capsule contents, not more than 10.0 per cent v/w (Azeotropic Distillation Method, Appendix 4.12).

Microbial limit Comply with the requirements for Category 4 in the “Limits for Microbial Contamination” (Appendix 10.5).

Dissolution Carry out the test as described in the “Dissolution Test for Herbal Drug Preparations” (Appendix 4.24H).

       Dissolution medium: 0.8 per cent w/v solution of sodium lauryl sulfate in 0.05 M hydrochloric acid; 900 mL. Prepare and use within 12 hours.

       Apparatus 1: 100 rpm.

       Time: 60 minutes.

     Determine the amount of curcuminoids dissolved, calculated as curcumin (C₂₁H₂₀O₆), using the following method.

         Standard curcumin solution Dissolve an accurately weighed quantity of curcumin in methanol. Dilute quantitatively with methanol to obtain a solution having a known concentration of about 400 μg of curcumin per mL.

         Standard curcumin curve Transfer into six 10-mL volumetric flasks, 10, 20, 40, 50, 60, and 80 μL 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.

         Test solution Withdraw a 15-mL aliquot and filter. Combine 5.0 mL of the filtered solutions of the six individual capsules withdrawn as the pooled sample and dilute to 50.0 mL with methanol. Transfer 10.0 mL of this solution into a 50-mL volumetric flask, dilute to volume with methanol and mix well.

          Procedure and Calculation Measure the absorbance of Test solution at the maximum at about 420 nm, using methanol as the blank (Appendix 2.2). By reference to the Standard curcumin curve, calculate the average content of curcuminoids as curcumin (C₂₁H₂₀O₆) dissolved

          Tolerances Not less than 75 per cent of the labelled amount of curcuminoids as curcumin is dissolved in 60 minutes.

Assay

          FOR VOLATILE OIL Grind the contents of not less than 20 Turmeric Capsules to fine powder. Transfer about 10 g, accurately weighed, to a 500-mL round-bottomed flask. Use 100 mL of water as the distillation liquid and distil at a rate of 2 to 3 mL per minute for 5 hours. Use 2.0 mL of xylene in the graduated tube (Appendix 7.3H). Calculate the content of volatile oil, in mL, in the portion of the Capsules taken with reference to the anhydrous substance.

          FOR CURCUMINOIDS 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 in methanol. Dilute quantitatively with methanol to obtain a solution having a known concentration of about 400 μg of curcumin per mL.

          Standard curcumin curve Transfer into five 10-mL volumetric flasks, 20, 40, 50, 60, and 80 μL 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. Plot the readings and draw the curve of best fit.

         Assay preparation Weigh and mix the contents of not less than 20 Turmeric Capsules. Transfer about 400 mg, accurately weighed, to a 25-mL Erlenmeyer flask and macerate with 10 mL of methanol. Set aside at room temperature for 6 hours with frequent shaking. Dilute 1.0 mL of the clear supernatant liquid with methanol to produce 25.0 mL. Transfer 1.0 mL of this solution into a 50-mL volumetric flask, dilute to volume with methanol and mix well.           

          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)