Angelica gigas Root
Angelica gigas Root
Proposed For Development Version 0.1
Angelica gigas Root
The article consists of the dried roots of Angelica gigas Nakai (Family Apiaceae). It contains NLT 4.2% of caffeoylquinic acid and total coumarins calculated as the sum of chlorogenic acid, demethylsuberosin, decursin, and decursinol angelate, on the dried basis.
POTENTIAL CONFOUNDING MATERIALS
Angelica acutiloba (Siebold & Zucc.) Kitag.
Angelica sinensis (Oliv.) Diels
SELECTED COMMON NAMES
English: Korean angelica, Korean tanggwi
CONSTITUENTS OF INTEREST
Coumarins: Decursin, decursinol, decursinol angelate, nodakenin
• A. Botanical Characteristics
Macroscopic: Conical or narrow long conical in shape, usually branched, 15–25 cm in length and 2–5 cm in diameter. The external surface is pale yellowish brown to blackish brown with irregular longitudinal wrinkles and spot-shaped remains of fibrous roots. The crown is broad, usually with remains of stems and leaves. The texture is hard but fragile. The fractured surface has a pale brown or yellowish brown cortex, relatively sparse with numerous clefts, and the xylem is white or yellowish white. This has a slight, characteristic odor, and a slightly bitter and sweet taste.
Microscopic: Under a microscope, the transverse section reveals cork consisting of 5–6 layers of cells, cells aligned transversely, parenchymas from primary cortex to xylem aligned systemically in rectangular shape. The cortex has schizogenous intercellular space, secretory canal with a yellowish brown ingredient and bast fiber bundles are sparsely scattered. Scalariform or spiral vessel is observed. Numerous starch grains are observed in parenchyma cells.
· B. HPTLC for Articles of Botanical Origin <203>
Standard solution: 1.0 mg/mL each of USP Imperatorin RS, USP Osthole RS, and USP Isoimperatorin RS in methanol
Sample solution: 1 g of Angelica gigas Root, finely powdered, in 5 mL of methanol. Sonicate for 10 min and centrifuge or filter. Use the supernatant or filtrate.
Adsorbent: Chromatographic silica gel F254 mixture
Application volume: 10 µL each of Standard solution 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, ethyl acetate, and acetic acid (90:10:1)
Developing distance: 6 cm
Samples: Standard solution and Sample solution
Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatograms in a saturated chamber (20 min with filter paper), remove the plate from the chamber, and examine under UV 365 nm light.
System suitability: To Come
Acceptance criteria: Under UV 365 nm light, the chromatogram of the Sample solution exhibits about 8 fluorescence bands in the lower half of the chromatogram. Three pale fluorescence bands apear above the broad fluorescence band near RF 0.25 corresponding in color and RF to the bands due to imperatorin, osthole, and isoimperatorin, with increasing RF in the Standard solution.
· C. HPLC
Analysis: Proceed as directed in the Assay for Content of Caffeoylquinic Acid and Total Coumarins.
Acceptance criteria: The Sample solution exhibits the most intense peak at a retention time corresponding to each Standard solution.
• Content of Caffeoylquinic Acid and Total Coumarins
Solution A: 0.1% formic acid in water
Solution B: 0.1% formic acid in acetonitrile
Mobile phase: See Table 1.
Solvent: Ethyl alcohol and water (7:3)
Standard solution A: 0.2 mg/mL of USP Chlorogenic Acid RS in methanol
Standard solution B: 0.8 mg/mL of USP Demethylsuberosin RS in methanol
Standard solution C: 2 mg/mL of USP Decursin RS in methanol
Standard solution D: 2 mg/mL of USP Decursinol Angelate RS in methanol
Sample solution: Accurately transfer about 1.0 g of finely powdered Angelica gigas Root to centrifugal tube, add 10 mL of Solvent, and weigh. Sonicate for 45 min, cool, and compensate the weight loss with Solvent. Before injection, pass through a membrane filter of 0.45-μm pore size.
(See Chromatography <621>, System Suitability.)
Detector: UV 325 nm
Column: 4.6-mm × 25-cm; packing L1
Column temperature: 40°
Flow rate: 1.0 mL/min
Injection volume: 10 µL
System suitability: To Come
Samples: Standard solutions A–D and Sample solution
Calculate the percentage of chlorogenic acid, demethylsuberosin, decursin, and decursinol angelate in the portion of Angelica gigas Root taken:
Result = (rU/rS) × CS × (V/W) × 100
rU = peak area of the corresponding analyte from the Sample solution
rS = peak area of the corresponding analyte from the Standard solution
CS = concentration of the Standard solution (mg/mL)
V = volume of the Sample solution, mL
W = weight of Angelica gigas Root taken to prepare the Sample solution, mg
Acceptance criteria: NLT 4.2% of caffeoylquinic acid and coumarins on the dried basis
• Elemental Impurities—Procedures <233>
Arsenic: NMT 3.0 µg/g
Cadmium: NMT 0.3 µg/g
Lead: NMT 5.0 µg/g
Mercury: NMT 0.2 µg/g
• Articles of Botanical Origin <561>, Pesticide Residue Analysis: 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 absence of Salmonella species and Escherichia coli
• Articles of Botanical Origin <561>, Test for Aflatoxins: Meets the requirements
• Articles of Botanical Origin <561>, Methods of Analysis, Foreign Organic Matter: NMT 5.0%
• Articles of Botanical Origin <561>, Methods of Analysis, Alcohol-Soluble Extractives, Method 1: To Come
• Articles of Botanical Origin <561>, Methods of Analysis, Water-Soluble Extractives, Method 2: To Come
• Loss on Drying <731>: To Come
• Articles of Botanical Origin <561>, Methods of Analysis, Total Ash: NMT 6.0%
• Articles of Botanical Origin <561>, Methods of Analysis, Acid-Insoluble Ash: To Come
• 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 Chlorogenic Acid RS
USP Decursin RS
USP Decursinol Angelate RS
USP Demethylsuberosin RS
USP Imperatorin RS
USP Isoimperatorin RS
USP Osthole RS
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