Sceletium tortuosum Aerial Parts

Sceletium tortuosum Aerial Parts

Proposed For Development Version 0.1

Sceletium tortuosum Aerial Parts


 

DEFINITION

The article consists of the dried aerial parts of Sceletium tortuosum (L.) N.E. Br. (Family Aizoaceae). It meets the Acceptance criteria under the Assay.

 

Synonyms

Mesembryanthemum tortuosum L.

Sceletium tortuosum (L.) N.E. Brown

 

Potential Confounding Materials

Aptenia species

 

Selected Common Names

African: Kanna, channa, kougoed (fermented article)

English: Sceletium

French: Sceletium

German: Sceletium

Italian: Sceletium

 

Constituents of Interest

Alkaloids: Mesembrine, mesembranol, mesembrenol, mesembrenone, and tortuosamine

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Prostrate to scrambling perennial succulent herb; fresh article is bright green, shiny and succulent; stem carries overlapping pairs of leaves that have shiny water cells (bladder cell idioblasts) on their surfaces; leaf is flat and triangular, with tips incurved, 30–40 mm long, 10–15 mm wide. The dried plant material appears fibrous with small greenish-brown leaves.

Microscopic: (To Come)

• B. Thin-Layer Chromatography

Standard solution A: 0.2 mg/mL of USP Mesembrine RS (To Come) in methanol

Standard solution B: 0.4 mg/mL of USP Sceletium tortuosum Alkaloids RS (To Come) in methanol. Sonicate if necessary.

Sample solution: Transfer about 2.0 g of Sceletium tortuosum Aerial Parts, powdered (500 µm mesh size), to a 30-mL centrifuge tube, add 24 mL of 0.5 M H2SO4, vortex for 15 s, and centrifuge at 5000 RPM for 15 min. Filter the supernatant into a separatory funnel, add 6.0 mL of 20% aqueous ammonia solution, mix, add 14 mL of dichloromethane, mix by gentle swirling for 10 min, and allow to separate. Filter the supernatant into a clean round-bottom flask. Repeat the extraction with dichloromethane, combine the filtrates, and evaporate under reduced pressure.  Dissolve 0.4 mg/mL of the residue in methanol. Sonicate if necessary.

Chromatographic system

(See Chromatography <621>, Thin-Layer Chromatography.

Adsorbent: Chromatographic silica gel with an average particle size 5 µm (HPTLC plates)

Application volume: 2 µL, as 8-mm bands

Relative humidity: Condition the plate to a relative humidity of about 47% using a suitable device.

Developing solvent system: Dichloromethane, methanol, and 10% ammonium hydroxide solution (90:10:0.1)

Developing distance: 7 cm

Derivatization reagent: Iodoplatinate reagent – 3 mg/mL hydrogen hexachloroplatinate (IV) hydrate in water.  Before use, dilute 1:1 with a solution of 6% potassium iodide in water.

Analysis 

Samples: Standard solution A, Standard solution B, and Sample solution

Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatogram in a saturated chamber, remove the plate from the chamber, and dry in air. Derivatize with Derivatization reagent and dry. Examine under visible light.

System suitability: The chromatogram of Standard solution B exhibits a brownish-violet band at an RF corresponding to the mesembrine band in the chromatogram of Standard solution A. Other bands shown in the chromatogram of Standard solution B include: the most intense band as a brownish-violet band at about the middle of the chromatogram; two brownish-violet bands in the lower-third section of the chromatogram, one close to the start due to mesembranol and the other at a higher RF due to mesembrenol; and a brownish-violet band in the upper-third section of the chromatogram, at a higher RF than that of mesembrine, due to mesembrenone. The bands due to mesembrine and mesembrenone are separated.

Acceptance criteria: The chromatogram of the Sample solution exhibits a band due to mesembrine corresponding in color and RF to the band in the chromatogram of Standard solution A, and the following bands corresponding to similar bands in the chromatogram of Standard solution B: the most intense band as a brownish-violet band at about the middle of the chromatogram, two brownish-violet bands in the lower-third section of the chromatogram due to mesembranol and mesembrenol, and a brownish-violet band in the upper-third section of the chromatogram due to mesembrenone.

 

ASSAY

• Content of Alkaloids

CALL FOR SUBMISSION OF VALIDATED INFORMATION

  

Additional information including validation data will be required to complete the development of the Assay. For requirements, please see under "Composition" and related sections in the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesresources.

 

Interested parties are encouraged to submit their proposals to complete the monograph.

 

CONTAMINANTS

Elemental Impurities—Procedures <233>

Acceptance criteria

Arsenic: NMT 2 µg/g

Cadmium: NMT 0.3 µg/g

Lead: NMT 5 µg/g

Mercury: NMT 0.2 µg/g

Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>: Meets the requirements

Microbial Enumeration Tests <61>: The total aerobic bacterial count does not exceed 105 cfu/g, the total combined molds and yeasts count does not exceed 103 cfu/g, and the bile-tolerant Gram-negative bacteria does not exceed 103 cfu/g.

Tests for Specified Microorganisms <62>: Meets the requirements of the tests for the absence of Salmonella species and Escherichia coli

 

SPECIFIC TESTS

Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 1%

Articles of Botanical Origin, Water-Soluble Extractives, Method 1 <561>: NLT 15% 

Loss on Drying <731>

Analysis: Dry 1.0 g of Sceletium tortuosum Aerial Parts, finely powdered, at 105° for 2 h.

Acceptance criteria: NMT 12%

Articles of Botanical Origin, Total Ash <561>

Analysis: 4.0 g of Sceletium tortuosum Aerial Parts, finely powdered

Acceptance criteria: NMT 5%

Articles of Botanical Origin, Acid-Insoluble Ash <561>

Analysis: 6.0 g of Sceletium tortuosum Aerial Parts, finely powdered

Acceptance criteria: NMT 1%

 

ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers, protected from light and moisture, and store at room temperature.

Labeling: The label states the Latin binomial and the parts of the plant contained in the article.

USP Reference Standards <11>

USP Mesembrine RS (To Come)

USP Sceletium tortuosum Alkaloids RS (To Come)

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