Peumus boldus Leaf

DEFINITION

The article consists of the dried leaves of Peumus boldus Molina (Family Monimiaceae). It meets the Acceptance criteria under the Assay.

SYNONYMS

Boldea boldus Molina (Looser)

Boldea fragrans (Pers.) Endl.

Boldu boldus (Molina) Lyons

Boldu chilanum Nees

Boldu chilensis Schult. & Schult. f.

POTENTIAL CONFOUNDING MATERIALS

Cryptocarya peumus: Morphological similarity

SELECTED COMMON NAMES

Bulgarian: Болдо

Chinese: 波爾多, 波耳多
Czech:  Boldovník vonný

English: Boldo, boldina, baldina

French: Boldo, feuille de boldo

German: Boldoblätter

Greek: Μπολντο

Hebrew: בולד, בּוֹלדוֹ

Hungarian: Boldo levél

Italian: Foglia di boldo

Japanese: ボルド(borudo)

Korean: 볼도, 볼도 리프

Lithuanian: Kvapusis čilmedis

Portuguese: Boldo

Russian: Болдо, Больдо

Slovak: Boldovník vonný

Spanish: Hoja de boldo

Swedish: Boldo

CONSTITUENTS OF INTEREST

Isoquinoline alkaloid: Boldine, isoboldine, isocorydine N-oxide, laurotetanine, isocorydine, N-methyllaurotetanine

Volatile oil: p-cymol, cineole, ascaridole

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Leaf is oval or elliptical, about 5 cm long with short petiole, an obtuse or slightly emarginate or mucronate apex; an equal and rounded base; margin is entire and slightly undulate with thickened edges that are more or less revolute; lamina is grayish-green, thick, tough and brittle; upper surface is rough with numerous prominent small protuberances and a depressed venation; lower surface is finely pubescent with the protuberances less well-marked, and a prominent, pinnate venation.

Microscopic

Transverse section: Dorsiventral with two layers of palisade composed of cells of nearly equal length. Upper epidermal cells are polygonal, thick-walled, indistinctly beaded; lower epidermal cells are somewhat larger; stellate clustered unicellular covering trichomes with more or less thickened and lignified walls on both epidermises; some epidermal cells show scars of fallen trichomes; hypodermis, usually of one layer but may be up to three or more layers, cells resembling those of the epidermis, thick-walled, pitted in both the anticlinal and periclinal walls; vascular strands contain narrow xylem elements, thick-walled sclerenchymatous fibers and lignified pitted parenchymatous cells. Numerous almost-spherical oil cells present in the spongy mesophyll. Aggregates of small, blunt-ended prismatic crystals present in many mesophyll cells. 

• B. Thin-Layer Chromatography

Standard solution A: 2.0 mg/mL of USP Boldine RS (To Come) in 5 mL methanol

Standard solution B: Mix 1 g of USP Peumus boldus Leaf Powder RS (To Come) with 10 mL of methanol, sonicate for 10 min, centrifuge, and use the supernatant.

Sample solution: Mix 1 g of Peumus boldus Leaf, finely powdered, with 10 mL of methanol, sonicate for 10 min, centrifuge, and use the supernatant.

Chromatographic system

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

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

Application volume: 2 µL of Standard solution A, and 6 µL each of Standard solution B and Sample solution; as 8-mm bands

Relative humidity: Condition the plate to a relative humidity of about 33% using a suitable device.

Developing solvent system: Toluene, methanol, and diethyl amine (80:10:10)

Developing distance: 6 cm

Derivatization reagent: 1% Iodine reagent. Dissolve 1 g of iodine in 100 mL of alcohol (C₂H₅OH).

Analysis

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

Apply the Samples as bands to a suitable HPTLC plate and dry. Develop the chromatogram in a saturated chamber, remove the plate from the chamber, and dry. Derivatize with Derivatization reagent, heat at 100° for 3 min, and examine under visible light.

System suitability: Standard solution B chromatogram exhibits, in the lower half, three brown bands. The lowest band corresponds in color and R_F to the boldine band in the chromatogram of Standard solution A. The chromatogram exhibits three bands in the upper half, in the following order of increasing R_F: a yellow band and two green bands.

Acceptance criteria: The Sample solution chromatogram exhibits a band corresponding in color and R_F to the boldine band in the chromatogram of Standard solution A. The Sample solution exhibits the following bands corresponding in color and R_F to similar bands in the chromatogram of Standard solution B: two brown bands in the lower half of the chromatogram at R_F above that of the boldine band, and three bands in the upper half, a yellow band and two green bands.

ASSAY

• Content of Isoquinoline 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 of 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.

• Volatile Oil Determination <561>

Sample: 10 g of Peumus boldus leaf, freshly and coarsely comminuted

Acceptance criteria: NLT 0.5% on the dried basis

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 4.0% of twigs and NMT 2.0% of other foreign matter

• Articles of Botanical Origin, Total Ash <561>

Analysis: 1.0 g of Peumus boldus leaf, finely powdered

Acceptance criteria: NMT 13%

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 Boldine RS (To  Come)

USP Peumus boldus Leaf Powder RS (To Come)