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          Senna Alata Tea contains an amount of powdered Senna Alata Leaf equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled content of  hydroxyanthracene derivatives, calculated as rhein-8-glucoside. 

Strength available  3 g (powder), supplied in a sachet.

Dose  One or two sachets, prepared as an infusion by soaking each with 120 mL of boiling water for 10 minutes, once a day at bedtime.

Warning  It should be used with caution in children .

Packaging and storage  Senna Alata Tea shall be kept in well-closed containers, protected from light.

Labelling  The label on the container states (1) the equivalent amount of hydroxyanthracene derivatives, calculated as rhein-8-glucoside; (2) the expiration date. 

Identification

          A. The tea contents exhibit diagnostic structures of the powdered drug described under Senna Alata Leaf.

          B. The tea contents comply with the tests for Identification A and B described under Senna Alata Leaf.

Loss on drying  Of the tea contents, not more than 11.0 per cent w/w after drying at 105° for 5 hours (Appendix 4.15).

Microbial limit  Complies with the requirements for Category 5 in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay  Grind the contents of not less than 20 sachets of Senna Alata Tea to fine powder. Transfer about 150 mg, accurately weighed, to a 100-mL round-bottomed flask.  Add 30.0 mL of water, mix, weigh, and place in a water-bath.  Heat under a reflux condenser for 15 minutes.  Allow to cool, weigh and adjust to the original weight with water.  Centrifuge and transfer 20.0 mL of the supernatant liquid to a 150-mL separator.  Add 0.1 mL of 2 M hydrochloric acid and shake with three 15-mL portions of chloroform.  Allow to separate and discard each chloroform layer.  Add 100 mg of sodium hydrogencarbonate and shake for 3 minutes.  Centrifuge and transfer 10.0 mL of the supernatant liquid to a 100-mL round- bottomed flask. Add 20 mL of a 10.5 per cent w/v solution of iron(III) chloride and mix.  Heat for 20 minutes under a reflux condenser in a water-bath with its water level above that of the liquid in the flask, add 1 mL of hydrochloric acid and heat for a further 20 minutes with frequent shaking,  to dissolve the precipitate.  Cool, transfer the mixture to a separator and shake with three  25-mL portions of ether previously used to rinse the flask.  Combine the ether layers and wash with two 15-mL portions of water.  Transfer the ether layers to a 100-mL volumetric flask and dilute with ether to volume.  Evaporate 25.0 mL carefully to dryness at a low temperature and dissolve the residue in 10.0 mL of a 0.5 per cent w/v solution of magnesium acetate in methanol.  Measure the absorbance of this solution at the maximum at about 515 nm (Appendix 2.2), using the magnesium acetate solution as the blank.  Calculate the quantity, in mg, of rhein-8-glucoside in the sample taken by the formula:

(446.37/284.22) (1200A/440),

in which 446.37 and 284.22 are the molecular weights of rhein-8-glucoside and rhein,  respectively, A is the absorbance of the solution at 515 nm and 440 is the specific absorbance.

Other requirements  Complies with the requirements described under “Herbal Teas” (Appendix 1.16H).