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ยาชงกระเจี๊ยบแดง (YA CHONG KRACHIAP DAENG)

Roselle Tea

Roselle Tea
Synonyms Sour Tea
Category Diuretic.

      Roselle Tea contains an amount of powdered Roselle equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of organic acids, calculated as citric acid on the dried basis.

Strengths available 2, 2.5 and 3 g (powder), supplied in a sachet.
Dose One sachet, containing 2 to 3 g of powdered roselle, prepared as an infusion by soaking each with 120 mL of boiling water for 10 minutes, three times a day after meals.
Contra-indication It is contra-indicated in patients with impaired renal function.

Warning
      1. It may cause abdominal discomfort.
      2. It may cause diarrhoea due to its laxative effect.
Packaging and storage Roselle Tea shall be kept in well-closed containers, protected from light, and stored at a temperature not exceeding 30°.
Labelling The label on the container states (1) the equivalent amount of organic acids calculated as citric acid; (2) the expiration date.

Identification
      A. The tea contents exhibit diagnostic structures of the powdered drug described under Roselle.
      B. The tea contents comply with the tests for Identification A, B and C described under Roselle.

Loss on drying  Of the tea contents, not more than 12.0 per cent w/w after drying at 105° to constant weight (Appendix 4.15).

Microbial limit Complies with the requirements for Category 2 in the “Limits for Microbial Contamination” (Appendix 10.5).

Assay  Grind the contents of not less than 20 sachets of Roselle Tea to No. 250 powder. Shake about 1 g, accurately weighed, with 100.0 mL of carbon dioxide-free water for 15 minutes and filter. To 50.0 mL of the filtrate, add 100 mL of carbon dioxide free-water. Titrate with 0.1 M sodium hydroxide VS until pH 7.0, determining the end-point potentiometrically (Appendix 6.4). Perform a blank determination, and make any necessary correction. Each mL of 0.1 M sodium hydroxide VS is equivalent to 6.4 mg of citric acid.

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

MONOGRAPHS • ยาชงกระเจี๊ยบแดง (YA CHONG KRACHIAP DAENG)
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หมายเหตุ / Note : THP2021 Page 349