Mangifera indica Bark Powder

Mangifera indica Bark Powder

Proposed For Development Version 0.1

Mangifera indica Bark Powder

 


DEFINITION

The article consists of the dried bark of Mangifera indica L. (Family Anacardiaceae) reduced to a fine or very fine powder. It contains NLT 2.5% of mangiferin, calculated on the dried basis.

 

POTENTIAL CONFOUNDING MATERIALS

None known

 

CONSTITUENTS OF INTEREST

Xanthon: Mangiferin and isomangiferin

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

Phenolic acid: Protocatechuic acid

 

IDENTIFICATION

• A. Botanical Characteristics

Macroscopic: Powder of bark is brown in color and shows fragments of cork cells in surface and sectional view.

Microscopic: Tannin tubes associated with fiber and stone cells; starch embedded in parenchymatous cells and scattered as such throughout; prismatic crystals of calcium oxalate; fragment of bark in tangential longitudinal section shows medullary ray cells; fibers associated with stone cells and calcium oxalate crystals; fragments of bark in radial longitudinal section shows medullary ray cells crossing over fibers and associated stone cells and calcium oxalate crystals; fragment of bark shows medullary ray cells, fibers, calcium oxalate crystals, and cells containing resin

• B. Thin-Layer Chromatography

Solvent: Methanol and DMF (90:10)

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

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

Sample solution: Sonicate about 2 g of Mangifera indica Bark Powder in 100 mL of Solvent 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: 10 µL each of Standard solution A, 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.

Temperature: 25°

Developing solvent system: Ethyl acetate, formic acid, acetic acid, and water (100:11:11:25)

Developing distance: 6 cm

Derivatization reagent: Anisaldehyde-sulfuric acid reagent

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. Treat with Derivatization reagent. Examine under visible light.

System suitability: Under visible light, Standard solution B exhibits, in the middle, a brown band appearing at slightly lower RF, with similar RF and color as the mangiferin band in Standard solution A. One purple band appears close to the solvent front.

Acceptance criteria: Under visible light, the Sample solution exhibits, in the middle, a brown band appearing at slightly lower RF, with similar RF and color as the mangiferin band in Standard solution A. One purple band appears close to the solvent front.

• C. HPLC

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

Solution A: Dissolve 0.136 g of potassium phosphate monobasic 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 0.45-μm pore size.

Sample solution: Transfer 0.2 g of Mangifera indica Bark Powder, accurately weighed, to a 50-mL volumetric flask. Add 40 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 0.45-μm pore size.

Chromatographic system

(See Chromatography <621>, System Suitability.)

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 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 A, Standard solution B, and Sample solution

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

Calculate the percentage of mangiferin in the portion of Mangifera indica Bark Powder 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 mangiferin in Standard solution A (mg/mL)

     = volume of the Sample solution (mL)

    = weight of Mangifera indica Bark Powder 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 10cfu/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 Powder

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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Other Versions

Proposed For Comment Version 0.2