Mangifera indica Bark

Mangifera indica Bark

Proposed For Comment Version 0.2

Mangifera indica Bark

 


DEFINITION

The article consists of the dried bark of Mangifera indica L. (Family Anacardiaceae). It contains NLT 2.5% of mangiferin, calculated on the dried basis.

 

SYNONYMS

Mangifera austroyunnanensis Hu

Rhus laurina Nutt.

 

POTENTIAL CONFOUNDING MATERIALS

None known

 

SELECTED COMMON NAMES

Chinese: 芒果

Czech: Amčur

English: Mango, Indian mango

French: Mangue, manguier

Hindi: आम

Japanese: アンチャー

Korean: 망고

Malay: Ampelan

Persian: انبه

Russian: Манго

Swahili: Maembre

Thai: มะม่วง

 

CONSTITUENTS OF INTEREST

Xanthon: Mangiferin and isomangiferin

Triterpenes: Cycloart-24-en-3β,26-diol

Phenolic acid: Protocatechuic acid

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Curved or channeled in shape, variable in length, 1.5–2.5 cm in thickness, outer surface is rough, dark brown in color, shows longitudinal fissures, ridges, transverse cracks and occasional protruding lenticels, older pieces of the bark shows shytidoma or patches of them attached at places, inner surface is longitudinally striated, yellowish or reddish in color, fracture, outer short, inner splintery, has characteristic odor.

Microscopic: Detailed transverse section of the dried old pieces of the bark shows outer wide zone of rhytidoma exhibiting various outer sections of the bark, due to penetration of the phellogen deep inside the cortical tissue. It is composed of cubical, rectangular or oblong, thin-walled, thick-walled, dark brown or lignified cells arranged in alternate bands of few or several rows, running tangentally or obliquely at places. Cortex is a wide parenchymatous zone traversed with isolated or groups of sclereids and stone cells of various sizes and thickness, phoem is a wider zone almost occupying half the region of the TS. Consists of isolated or small groups of lignified thick-walled fibers, arranged in irregularly running tangential bands towards the inner region, alternating with uni- to bi-semiate parenchymatous medullary rays, but becoming sclerosed at places especially when they pass through the fibrous tissue, almost running parallel to each other but becoming wider and running irregularly in the peripheral region; spherical schizogenous, isolated or occasionally in small groups of secretary tannin and resin channels traversed throughout the parenchymaotus tissue of the phloem; the prismatic crystals of calcium oxalate and starch grains are embedded throughout the paranchymatous cells of the section.

• B. Thin-Layer Chromatography

Standard solution A: 0.15 mg/mL of USP Mangiferin RS in methanol

Standard solution B: 5 mg/mL of USP Mangifera indica Bark Dry Extract RS in methanol. Sonicate for 10 min, centrifuge, and use the supernatant.

Sample solution: Sonicate about 0.2 g of Mangifera indica Bark, finely powdered, in 10 mL of methanol for 10 min, centrifuge, and use the supernatant.

Chromatographic system

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

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

Application volume: 4 µL each of Standard solution A and Standard solution B, and 2 µL of 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: Ethyl acetate, formic acid, and water (80:10:10)

Developing distance: 7 cm

Temperature: 25“

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 chromatograms in a saturated chamber, remove the plate from the chamber, and dry. Examine under UV 254 and 366 nm.

System suitability: Under UV 254 nm, the chromatogram of Standard solution B exhibits a black band similar in RF to mangiferin in the chromatogram of Standard solution A. One weak band appears right above the origin and two weak bands appear above the mangiferin band. Under UV 366 nm, the chromatogram of Standard solution B exhibits a weak blue band similar in color and RF to mangiferin in the chromatogram of Standard solution A. About six additional bands appear with increasing RF: a pale white/yellow band near the origin, a bright orange band slightly below the mangiferin band, a pale orange band above the mangiferin band, two blue bands near RF of about 0.75, and a blue band near the solvent front.

Acceptance criteria: Under UV 254 nm, the chromatogram of Sample solution exhibits a band corresponding in color and RF to the mangiferin band in the chromatogram of Standard solution A. One weak band appears right above the origin. Under UV 366 nm, the chromatogram of Sample solution exhibits a weak blue band similar in color and RF to mangiferin in the chromatogram of Standard solution A. About six additional bands appear with increasing RF: a pale white/yellow band near the origin, a pale orange band slightly below the mangiferin band, a pale orange band above mangiferin band, two blue bands near RF of about 0.75, and a pale blue band near the solvent front.

• C. HPLC

Analysis: Proceed as directed in the Assay for Content of Mangiferin.

Acceptance criteria: The chromatogram of the Sample solution exhibits peaks at retention times corresponding to the peaks due to mangiferin in Standard solution B.

 

ASSAY

• Content of Mangiferin

Solution A: Dissolve 0.136 g of monobasic potassium phosphate in 900 mL of water, add 0.5 mL of o-phosphoric acid, dilute with water to 1 L, and mix.

Solution B: Acetonitrile

Mobile phase: See Table 1

 

Table 1

Time
(min)

Solution A
(%)

Solution B
(%)

0.01

85

15

10

80

20

15

80

20

20

85

15

25

85

15

 

Solvent: 70% Methanol in water

Standard solution A: 0.1 mg/mL of USP Mangiferin RS in Solvent

Standard solution B: Accurately weigh USP Mangifera indica Bark Dry Extract RS, equivalent to 10 mg of mangiferin, into a 100-mL volumetric flask, add 50 mL of Solvent, and dissolve in a boiling water bath for 15 min with sonication. Cool the solution and dilute with Solvent to volume. Mix well and pass through a membrane filter of 0.45-μm pore size.

Sample solution: Transfer 0.2 g of Mangifera indica Bark, finely powdered and accurately weighed, to a 100-mL volumetric flask. Add 50 mL of boiling Solvent and sonicate for 10 min. Dilute with water to 100 mL, mix well, and pass through a membrane filter of 0.45-μm pore size.

Chromatographic system

(See Chromatography <621>, System Suitability.)

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-µm packing L1 (similar to Merck kGaA Purospher Star LP HPLC Column, RP-18)

Flow rate: 1.5 mL/min

Injection volume: 20 µL

System suitability

Samples: Standard solution A and Standard solution B

Suitability requirements

Chromatogram similarity: The chromatogram of Standard solution B is similar to the reference chromatogram provided with the lot of USP Mangifera indica Bark Dry Extract RS being used.

Tailing factor: NMT 1.5, Standard solution A

Relative standard deviation: NMT 2.0%, Standard solution A

Analysis

Samples: Standard solution AStandard solution B, and Sample solution

Using the chromatograms of Standard solution AStandard solution B, and the reference chromatogram provided with the lot of USP Mangifera indica Bark Dry Extract RS being used, identify the retention times of the peaks corresponding to mangiferin.

Calculate the percentage of mangiferin in the portion of Mangifera indica Bark taken:

 

Result = (rU/rS) × CS × (V/W) × 100

 

rU     = peak area of mangiferin in the Sample solution

rS     = peak area of mangiferin in Standard solution A

CS    = concentration of USP Mangiferin RS from Standard solution A (mg/mL)

V      = volume of the Sample solution (mL)

W     = weight of Mangifera indica Bark taken to prepare the Sample solution (mg)

Acceptance criteria: NLT 2.5% on the dried basis

 

CONTAMINANTS

• Elemental Impurities—Procedures <233>

Acceptance criteria

Arsenic: NMT 2.0 µg/g

Cadmium: NMT 1.0 µg/g

Lead: NMT 5.0 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 2.0%

• Articles of Botanical Origin, Alcohol-Soluble Extractives, Method 1 <561>: NLT 20.0%

• Articles of Botanical Origin, Water-Soluble Extractives, Method 2 <561>: NLT 14.0%

• Loss on Drying <731>

Sample: 1 g of Mangifera indica Bark, finely powdered

Analysis: Dry the Sample at 105° for 2 h.

Acceptance criteria: NMT 8%

• Articles of Botanical Origin, Total Ash <561>: NMT 9%

• Articles of Botanical Origin, Acid-Insoluble Ash <561>: NMT 2%

 

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 Mangifera indica Bark Dry Extract RS

USP Mangiferin RS 

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