สารบัญ

       Cannabis Sativa Leaf Tea contains an amount of powdered Cannabis Sativa Leaf equivalent to not less than 90.0 per cent and not more than 110.0 per cent of the labelled amount of tetrahydrocannabinol (C₂₁H₃₀O₂), calculated on the dried basis.

Strength available 1 g (powder), supplied in a sachet.

Dose One sachet, prepared as an infusion by soaking each with 180 to 250 mL of boiling water for 5 minutes, once daily.

Warning

       1. Ingestion of powdered cannabis sativa leaves is not recommended.

       2. It may cause drowsiness, dizziness, headache, nausea and vomiting, and/or low blood pressure.

       3. Concomitant use with alcohol, cannabis- and/or caffeine- containing products should be avoided.

       4. Risk-benefit should be considered if it is to be used in pregnant or nursing women, adults under 25 years of age, children, and patients with a known history of mental illnesses or compromised cardiovascular symptoms.

Packaging and storage Cannabis Sativa Leaf 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 amount of tetrahydrocannabinol in mg per sachet; (2) the expiration date.

Identification

       A. The tea contents exhibit diagnostic structures of the powdered drug described under Cannabis Sativa Leaf.

       B. The tea contents comply with the tests for Identification A, B, and C described under Cannabis Sativa Leaf.

Loss on drying Of the Tea contents, not more than 9.0 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 Carry out the determination as described in the “Liquid Chromatography” (Appendix 3.5).

       Mobile phase A Use acetonitrile.

       Mobile phase B Prepare a 0.1 per cent v/v solution of trifluoroacetic acid.

       Standard stock preparation Use a solution containing 1 mg per mL of Tetrahydrocannabinol RS in ethanol (Lipomed® or equivalent is suitable.).

       Standard preparations Transfer 1.0 mL of Standard stock preparation to a 50-mL volumetric flask, dilute with acetonitrile to volume, and mix. Dilute the solution quantitatively and stepwise with the same solvent to obtain five solutions having known concentrations of 2, 4, 6, 8, and 10 μg per mL.

        Assay preparation Grind the contents of not less than 20 sachets of Cannabis Sativa Leaf to fine powder. Sonicate about 400 mg, accurately weighed, in 20.0 mL of acetonitrile for 20 minutes, and filter. Transfer 1.0 mL of the filtrate to a 20-mLvolumetric flask, dilute to volume with acetonitrile, and mix. Filter through a nylon membrane having a 0.45-μm porosity. (Note In case the concentration of tetrahydrocannabinol in the Assay preparation is not in the concentration range of standard curve, allow to adjust the volume of the filtrate taken.)

The step gradient of mobile phases is as follows:

       Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (2.7 µm), equipped with a similarly packed guard column (5 mm × 3.9 mm), and maintained at a temperature of 35°±1°, (b) Mobile phase at a flow rate of about 1.8 mL per minute, and (c) an ultraviolet photometer set at 228 nm.

       To determine the suitability of the chromatographic system, chromatograph Standard preparation having a known concentration of 6 μg per mL, and record the peak response as directed under Procedure and Calculation: the relative standard deviation for replicate injections is not more than 2.0 per cent.

       Procedure and Calculation Separately inject about 25 μL each of Standard preparations into the chromatograph, record the chromatograms, and measure the responses for tetrahydrocannabinol peaks. Plot the readings and draw the standard curve of best fit: the curve shows the correlation coefficient of not less than 0.999. Inject about 25 μL of Assay preparation into the chromatograph, record the chromatogram, and measure the response for tetrahydrocannabinol peak. By reference to the standard curve, calculate the content of tetrahydrocannabinol (C₂₁H₃₀O₂) in the portion of the Tea taken.

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