Hibiscus sabdariffa Flower
Hibiscus sabdariffa Flower
Proposed For Development Version 0.1
Hibiscus sabdariffa Flower
The article consists of the dried whole or cut calyces and epicalyces of Hibiscus sabdariffa L. (Family Malvaceae) collected during fruiting. It meets the Acceptance criteria under the Assay.
Abelmoschus cruentus (Bertol.) Walp.
Furcaria sabdariffa Ulbr.
Hibiscus cruentus Bertol.
Hibiscus fraternus L.
Hibiscus palmatilobus Baill.
Sabdariffa rubra Kostel.
POTENTIAL CONFOUNDING MATERIALS
Leaves of other Hibiscus spp. including H. cannabinus L. and H. acetosella Welw. ex Hiern.
Other plant parts of Hibiscus sabdariffa L.
SELECTED COMMON NAMES
Arabic: كركديه ,روزيلا
English: Jamaican sorrel, Indian sorrel, Java jute, karkade, red sorrel, red tea, roselle, rosella, royal roselle, Florida cranberry, rozelle, Guinea sorrel, sorrel, sour-sour, Queensland jelly plant, jelly okra
French: Oseille de Guinée, thé rose d'Abyssinie
German: Afrikanischer eibisch, hibiscus-tee, Karkade-tee, rosella, roselle, rote malve, malventee
Japanese: ロゼル, ローゼル
Pinyin: Mei gui qie, Shan qie zi
Polish: Hibiskus szczawiowy, ketmia szczawiowa
Portuguese: Carurú-de-Guiné, quiabo-azedo , quiabo-de-Angola, quiabo-róseo, quiabo-roxo, rosella, vinagreira (Brazil)
Spanish: Acedera de Guinea, rosa de Jamaica, serení
Thai: กระเจี๊ยบ, กระเจี๊ยบแดง
CONSTITUENTS OF INTEREST
Anthocyanins: Delphinidin-3-O-sambubioside, cyanidin-3-O-sambubioside, cyanidin-3-O-rutinoside, delphinidin-3-O-glucoside, and cyanidin-3,5-diglucoside
Organic acids: Citric acid, malic acid, tartaric acid, and (+) allohydroxycitric acid lactone (hibiscus acid)
• A. Botanical Characteristics
Macroscopic: The calyx is joined in the lower half to form an urceolate structure, the upper half dividing to form five long acuminate recurved tips. The tips have a prominent, slightly protruding midrib and a large, thick nectary gland about 1 mm in diameter. The epicalyx consists of 8–12 small, obovate leaflets, which are adnate to the base of the calyx. The calyx and epicalyx are fleshy, dry, easily fragmented, bright red or deep purple, somewhat lighter at the base of the inner side.
Microscopic: Epidermis cells, some containing cluster crystals of calcium oxalate, unicellular, long and twisted covering trichomes, rigid, straight, unicellular covering trichomes, simple or in groups of 2–4, glandular trichomes with a unicellular stalk and a globular or oval, multicellular and biseriate head; underlying parenchyma with slightly thickened walls, some containing cluster crystals of calcium oxalate, while others are filled with mucilage.
• B. Thin-Layer Chromatography
Standard solution A: 0.25 mg/mL each of quinaldine red and sulfan blue in methanol
Standard solution B: Sonicate about 1 g of USP Hibiscus sabdariffa Flower Powder RS (To Come) in 10 mL of methanol for 10 min, centrifuge, and use the supernatant.
Sample solution: Sonicate about 1 g of Hibiscus sabdariffa Flower, finely powdered, in 10 mL of methanol for 15 min, centrifuge, and use the supernatant.
(See Chromatography <621>, Thin-Layer Chromatography.)
Adsorbent: Chromatographic silica gel with an average particle size 5 µm (HPTLC plates)
Application volume: 2 µL each of Standard solution A and Standard solution B and 6 µL of Sample solution, as 8-mm bands
Relative humidity: Condition the plate to a relative humidity of about 30% using a suitable device.
Developing solvent system: n-Butanol, water, and formic acid (40:12:10)
Developing distance: 6 cm
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 chromatograms in a saturated chamber, remove the plate from the chamber and dry. Examine under visible light.
System suitability: The chromatogram of Standard solution B exhibits the most intense band as a blue band at an RF below the band corresponding to sulfan blue in the chromatogram of Standard solution A. Other bands shown in the chromatogram of Standard solution B include a violet band at an RF above the sulfan blue band and a minor yellow band at an RF below that of the quinaldine red band in Standard solution A.
Acceptance criteria: The Sample solution exhibits a blue band (the most intense) and a violet band in the lower half of the chromatogram, and a minor yellow band in the upper half. These bands correspond in color and RF to similar bands in the chromatogram of Standard solution B.
• 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-noticesresources
Interested parties are encouraged to submit their proposals to complete the monograph.
• Elemental Impurities—Procedures <233>
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
• Coloring Intensity
Analysis: To 1.0 g of Hibiscus sabdariffa Flower, finely powdered, add 25 mL of boiling water and heat for 15 min on a water-bath with frequent shaking. Filter the hot mixture into a 50-mL volumetric flask; rinse the residue and filter successively three times with 5 mL of warm water, and add to the 50-mL flask. Allow to cool, dilute with water to volume, and mix. Dilute 5.0 mL of this solution with water to 50.0 mL. Measure the absorbance at 520 nm using water as the blank.
Whole: NLT 0.350
Cut article: NLT 0.250
• Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 2% of fragments of fruits (red funicles and parts of the 5-caverned capsule with yellowish-grey pericarp, whose thin walls consist of several layers of differently directed fibers; flattened, reniform seeds with a dotted surface) and NMT 2% of other foreign matter.
• Loss on Drying <731>
Analysis: Dry 1.0 g Hibiscus sabdariffa Flower, finely powdered, at 105° for 2 h.
Acceptance criteria: NMT 11%
• Articles of Botanical Origin, Total Ash <561>
Analysis: 2.0 g of Hibiscus sabdariffa Flower, finely powdered
Acceptance criteria: NMT 10%
• 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 Powdered Hibiscus sabdariffa Flower RS (To Come)
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