Piper methysticum Rootstock

Piper methysticum Root and Rhizome

Proposed For Development Version 0.1

Piper methysticum Rootstock

 


 

DEFINITION

The article consists of the dried rootstock (rhizome) of Piper methysticum  G. Forst. (Family Piperaceae). It meets the Acceptance criteria under the Assay (to come).

 

SYNONYMS

None known

 

POTENTIAL CONFOUNDING MATERIALS

Piper wichmannii C.DC.

Piper methysticum  var. wichmannii (C.DC.) Lebot.

 

SELECTED COMMON NAMES

English: Kava, kava-kava, kava pepper

Fijian: Yaqona

French: Ava, kawa-kawa

German: Kawapfeffer

Spanish: Kavaka

 

CONSTITUENTS OF INTEREST

Kavalactones: Kawain (kavain), dihydrokavain, methysticin, yangonin, and desmethoxyyangonin

Chalconoids: Flavokavain A–C

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Occurs in irregular longitudinal and transverse cut pieces of various shapes and thicknesses. The rhizome is 3–20 cm long and 1–10 cm thick. The outer surface of the peeled rhizome is whitish or pale grayish-brown; the inner surface is white to yellowish-white with light and dark brown areas. The fracture is coarsely fibrous and starchy. In a transverse section, the lighter colored sunken pith, surrounded by a radiate xylem crossed by fans of rays, is visible; in some cases, a thin layer of cork may be present. In older rhizomes numerous splits and cavities, resulting from the loss of parenchyma from the central region, are visible. The unpeeled rhizome has a gray to grayish-brown, longitudinally wrinkled outer layer of cork with circular root scars. If not removed, fringe of long lateral roots that filiform at the end extend from the pithy rootstock. The roots are often interwined in a braid-like formation. The roots comprise a multitude of fibers that are rich in starch.

Microscopic: The entire medullary parenchyma, the medullary rays, and the centeral cortex are very rich in starch; the parenchyma also contains a fine-grained brown material and some resinous masses. The starch granules are spherical to slightly ovoid, 10–30 µm in diameter, with a central hilum in the form of a cleft or deep split. The primary cortex contains strips of collenchymas, and frequently contains oleoresin excretory cells with greenish-yellow, resinous contents, and contains stone cells covering the phloem. The stone cells have uniform, non-pitted wall thickenings, and are approximately polygonal in shape, with a diameter of about 50 µm. The unpeeled rhizome has a thin-walled cork layer. The center of a transverse section of the rhizome contains primary xylem elements in narrow strops formed mainly by tracheid-like elements, and secondary xylem elements with strands of lignified vascular tissue that extend evenly around the medulla and alternate with broad secondary medullary rays. The secondary vascular elements consist of large xylem vessels with scalariform thickening, groups of thicker-walled fibers with bluntly narrowing ends, and abundant parenchymatous cells with moderately-thickened walls and numerous pits. Additional vascular bundles are scattered throughout the medulla. The phloem contains extremely delicate, thin-walled cells. A transverse section through the radicles occasionally reveals a macrocellular, slightly suberose primary cortex composed of thin-walled polygonal cells; a narrow strip of secondary cortex clearly separated from the primary cortex by a dark brown endodermis; broad medullary rays; and a macrocellular, parenchymatous medulla. There are no calcium oxalate crystals present.

• B. Thin-Layer Chromatography

 

CALL FOR SUBMISSION OF VALIDATED INFORMATION

 

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

 

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

 

ASSAY

• Content of Constituents of Interest

 

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 of the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesguidelines

 

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

 

CONTAMINANTS

• Elemental Impurities—Procedures <233>

Acceptance criteria

Arsenic: NMT 2.0 µg/g

Cadmium: NMT 0.5 µg/g

Lead: NMT 5.0 µg/g

Mercury: NMT 0.1 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

• Articles of Botanical Origin, Test for Aflatoxins <561>: Meets the requirements

 

SPECIFIC TESTS

• Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1 <561>: NLT 10.0%

• Articles of Botanical Origin, Water-Soluble Extractives, Method 2 <561>: NLT 20.0%

• Articles of Botanical Origin, Total Ash <561>: NMT 7%

• Articles of Botanical Origin, Acid-Insoluble Ash <561>: 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 part(s) of the plant contained in the article.

• USP Reference Standards <11>

USP Kawain RS

USP Powdered Kava Extract RS

 
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Other Versions

Final Authorized Version 1.0
Proposed For Comment Version 0.2