Garcinia cambogia
DEFINITION
Garcinia cambogia consists of the dried pericarp of the fruits of Garcinia gummi-gutta (L.) N. Robson, also known as Garcinia cambogia (Gaertn.) Desr. (Fam. Clusiaceae). It contains NLT 12% of the sum of (–)-hydroxycitric acid and (–)-hydroxycitric acid lactone, on the dried basis.
IDENTIFICATION
• A.
Garcinia cambogia meets the requirements under Specific Tests, Botanic Characteristics.
• B. HPLC Identification Test:
The Sample solution chromatogram exhibits a peak for hydroxycitric acid at a retention time corresponding to that of Standard solution A, as obtained in the test for Content of (–)-Hydroxycitric Acid and (–)-Hydroxycitric Acid Lactone. The Sample solution also exhibits a peak for hydroxycitric acid lactone. The hydroxycitric acid and the hydroxycitric acid lactone peaks are the main peaks in the Sample solution chromatogram.
COMPOSITION
• Content of (–)-Hydroxycitric Acid and (–)-Hydroxycitric Acid Lactone
Solution A:
30% phosphoric acid in water
Mobile phase:
Dissolve 1.36 g of anhydrous potassium dihydrogen phosphate in 900 mL of water, adjust with Solution A to a pH of 2.5, complete to 1000 mL with water, mix, filter, and degas.
Solvent:
A mixture of Solution A and water (1:9)
Standard solution A:
A solution of USP Calcium (–)-Hydroxycitrate RS equivalent to about 2.5 mg/mL of (–)-hydroxycitric acid in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Standard solution B:
5 mg/mL of USP Powdered Garcinia Hydroxycitrate Extract RS in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size.
Sample solution:
Transfer about 5 g of Garcinia cambogia, finely powdered and accurately weighed, to a 250-mL round-bottom flask fitted with a reflux condenser. Add 50 mL of Solvent, reflux while stirring on a water bath for 30 min, set aside to settle, and decant the supernatant. Repeat the extraction using four 50-mL portions of water, combine all extracts, cool, filter into a 250-mL volumetric flask, and complete with water to volume. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Chromatographic system
Mode:
LC
Detector:
UV 215 nm
Column:
4.6-mm × 25-cm; packing L1
Column temperature:
25 ± 1
Flow rate:
1.0 mL/min
Injection size:
20 µL
System suitability
Samples:
Standard solution A, Standard solution B, and Sample solution
[Note—The relative retention times for the hydroxycitric acid lactone and hydroxycitric acid peaks are about 0.9 and 1.0, respectively. ]
Suitability requirements
Chromatogram similarity:
The chromatogram from Standard solution B is similar to the reference chromatogram provided with the lot of USP Powdered Garcinia Hydroxycitrate Extract RS being used.
Resolution:
NLT 1.0 between hydroxycitric acid lactone and hydroxycitric acid, Sample solution
Tailing factor:
NMT 2.0 for the hydroxycitric acid peak, Standard solution A
Relative standard deviation:
NMT 2.0%, determined from the hydroxycitric acid peak in repeated injections, Standard solution A
Analysis
Samples:
Standard solution A, Standard solution B, and Sample solution. [Note—Standard solution A, Standard solution B, and Sample solution are stable for 6 h. ]
Calculate the percentages of (–)-hydroxycitric acid and (–)-hydroxycitric acid lactone in the portion of Garcinia cambogia taken:
Result = (rU/rS) × CS × (V/W) × F × 100
| rU | = | = peak area of the relevant analyte from the Sample solution |
| rS | = | = peak area of hydroxycitric acid from Standard solution A |
| CS | = | = concentration of (–)-hydroxycitric acid in Standard solution A (mg/mL) |
| V | = | = final volume of the Sample solution (mL) |
| W | = | = weight of Garcinia cambogia used to prepare the Sample solution (mg) |
| F | = | = conversion factor for each analyte: 2.17 for (–)-hydroxycitric acid lactone, and 1.00 for (–)-hydroxycitric acid |
Acceptance criteria:
Add the percentages of (–)-hydroxycitric acid and (–)-hydroxycitric acid lactone: NLT 12% is found on the dried basis.
IMPURITIES
Inorganic Impurities
• Heavy Metals, Method III 
231
:
NMT 20 ppm
231:
NMT 20 ppm
Organic Impurities
• Procedure 1: Articles of Botanical Origin, Foreign Organic Matter 561:
NMT 2.0%
561:
NMT 2.0%
• Procedure 2: Articles of Botanical Origin, General Method for Pesticide Residues Analysis 561:
Meets the requirements
561:
Meets the requirements
SPECIFIC TESTS
• Botanic Characteristics
Macroscopic:
Fresh fruits are spherical to oval in shape, 4–8 cm in height, 3–6 cm in width, yellowish to pale pinkish when ripe, resemble a miniature pumpkin, with 7–13 deep longitudinal grooves, extending up to a circular elevated base of stigma with blackish tip, situated in the depressed end of the fruit, containing 6–8 seeds surrounded by a succulent aril. Compendial article consists of dried pieces of pericarp, longitudinal, of variable size and shape, strongly curved inward; leathery; externally rough, irregularly wrinkled, longitudinally grooved; internally smooth, longitudinally faintly striated and ridged. Dark brown to blackish-brown; odor characteristic; taste sour, astringent, and slightly bitter.
Histology
Transverse section of the pericarp:
Shows a layer of epicarp, composed of rectangular to tangentially elongated cells covered with thin cuticle; wide mesocarp, composed of 100–150 rows of parenchyma cells of variable size and shape, the outer rows composed of relatively larger cells with wide intercellular spaces; vascular bundles appear throughout the mesocarp, more toward the inner zone; dark brown gummy exudates, simple and compound starch granules and prisms of calcium oxalate are present in the parenchyma cells throughout the mesocarp.
• Limit of Citric Acid
Solvent and Chromatographic system:
Prepare as directed in the test for Content of (–)-Hydroxycitric Acid and (–)-Hydroxycitric Acid Lactone.
Standard solution:
0.5 mg/mL of USP Citric Acid RS in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size, discarding the first few mL of the filtrate.
Analysis
Sample:
Standard solution
Calculate the percentage of citric acid in the portion of Garcinia cambogia taken:
Result = (rU/rS) × CS × (V/W) × 100
| rU | = | = peak area of citric acid from the Sample solution in the test for Content of (–)-Hydroxycitric Acid and (–)-Hydroxycitric Acid Lactone (mg/mL) |
| rS | = | = peak area of citric acid from the Standard solution |
| CS | = | = concentration of USP Citric Acid RS in the Standard solution (mg/mL) |
| V | = | = final volume of the Sample solution (mL) |
| W | = | = weight of Garcinia cambogia used to prepare the Sample solution in the test for Content of (–)-Hydroxycitric Acid and (–)-Hydroxycitric Acid Lactone (mg) |
Acceptance criteria:
NMT 2% of citric acid on the dried basis
• Loss on Drying 731:
Dry 2.0 g of finely powdered Garcinia cambogia at 105 for 3 h: it loses NMT 12.0% of its weight.
731:
Dry 2.0 g of finely powdered Garcinia cambogia at 105 for 3 h: it loses NMT 12.0% of its weight.
• Articles of Botanical Origin, Total Ash 561:
Determined on 1.0 g of finely powdered Garcinia cambogia: NMT 3.0%; and NMT 8.0% if sodium chloride was added as a preservative during collection of the fruits
561:
Determined on 1.0 g of finely powdered Garcinia cambogia: NMT 3.0%; and NMT 8.0% if sodium chloride was added as a preservative during collection of the fruits
• Microbial Enumeration Tests 2021:
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 do not exceed 103 cfu/g.
2021:
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 do not exceed 103 cfu/g.
• Microbiological Procedures for Absence of Specified Microorganisms 2022:
Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
2022:
Meets the requirements of the tests for absence of Salmonella species and Escherichia coli
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, following the official name, the part of the plant contained in the article.
• USP Reference Standards 11
11
USP Calcium (–)-Hydroxycitrate RS
USP Citric Acid RS 
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USP Powdered Garcinia Hydroxycitrate Extract RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Maged H. Sharaf, Ph.D.
Principal Scientific Liaison 1-301-816-8318 |
(DS2010) Monographs - Dietary Supplements |
| 2021 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 2022 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 1302
Pharmacopeial Forum: Volume No. 36(3) Page 699