Powdered Garcinia Hydroxycitrate Extract
DEFINITION
Powdered Garcinia Hydroxycitrate Extract is prepared from Garcinia cambogia or Garcinia indica by extraction with water, alcohol, or mixtures of these solvents, followed by stabilization of the (–)-hydroxycitric acid content in the form of a calcium, potassium, magnesium, and/or sodium salt. The ratio of plant material to extract is about 5:1 to 10:1. It contains NLT 40% of (–)-hydroxycitric acid, calculated on the dried basis. It may contain suitable added substances.
IDENTIFICATION
• A. 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 Limit of (–)-Hydroxycitric Acid Lactone.
COMPOSITION
• Content of (–)-Hydroxycitric Acid and Limit of (–)-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.
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:
5 mg/mL of Powdered Garcinia Hydroxycitrate Extract in Solvent. Before injection, pass through a membrane filter of 0.45-µm or finer pore size.
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 and Standard solution B
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.
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, Standard solution A
Analysis
Samples:
Standard solution A, Standard solution B, and Sample solution. [Note—Standard solution A, Standard solution B, and the Sample solution are stable for 6 h. ]
Calculate the percentage of (–)-hydroxycitric acid and the limit of (–)-hydroxycitric acid lactone, if present, in the portion of Powdered Garcinia Hydroxycitrate Extract taken:
Result = (rU/rS) × (CS/CU) × F × 100
| rU | = | = peak area for 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) |
| CU | = | = concentration of Powdered Garcinia Hydroxycitrate Extract in the Sample solution (mg/mL) |
| F | = | = conversion factor for each analyte: 2.17 for (–)-hydroxycitric acid lactone, and 1.00 for (–)-hydroxycitric acid |
Acceptance criteria:
NLT 40% of (–)-hydroxycitric acid and NMT 8% of (–)-hydroxycitric acid lactone on the dried basis
IMPURITIES
Inorganic Impurities
• Heavy Metals, Method III 
231
:
NMT 20 ppm
231:
NMT 20 ppm
Organic Impurities
• Procedure: Articles of Botanical Origin, Pesticide Residues 561:
Meets the requirements
561:
Meets the requirements
SPECIFIC TESTS
• Limit of Citric Acid
Solvent:
Prepare as directed in the test for Content of (–)-Hydroxycitric Acid and Limit of (–)-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.
Analysis
Sample:
Standard solution
Calculate the percentage of citric acid in the portion of Powdered Garcinia Hydroxycitrate Extract taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak area of citric acid, using the peak area of citric acid from the Sample solution in the test for Content of (–)-Hydroxycitric Acid and Limit of (–)-Hydroxycitric Acid Lactone |
| rS | = | = peak area of citric acid from the Standard solution |
| CS | = | = concentration of USP Citric Acid RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Powdered Garcinia Hydroxycitrate Extract in the Sample solution in the test for Content of (–)-Hydroxycitric Acid and Limit of (–)-Hydroxycitric Acid Lactone (mg/mL) |
Acceptance criteria:
NMT 5% of citric acid on the dried basis
• Identification Tests—General 191:
Test for the presence of calcium, magnesium, potassium, and/or sodium.
191:
Test for the presence of calcium, magnesium, potassium, and/or sodium.
• Loss on Drying 731:
Dry 2.0 g of Powdered Extract at 105 for 3 h: Powdered Extract containing calcium hydroxycitrate loses NMT 5.0% of its weight; Powdered Extract containing other salts loses NMT 9.0% of its weight.
731:
Dry 2.0 g of Powdered Extract at 105 for 3 h: Powdered Extract containing calcium hydroxycitrate loses NMT 5.0% of its weight; Powdered Extract containing other salts loses NMT 9.0% of its weight.
• Microbial Enumeration Tests 2021:
The total aerobic bacterial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does not exceed 103 cfu/g.
2021:
The total aerobic bacterial count does not exceed 104 cfu/g, and the total combined molds and yeasts count does 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.
• Other Requirements:
It meets the requirements of the test for Residual Solvents under Botanical Extracts 565.
565.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers, protected from light and moisture, and store at controlled room temperature.
• Labeling:
The label states the Latin binomial and, following the official name, the part of the plant from which the article was prepared. It meets other Labeling requirements under Botanical Extracts 565.
565.
• 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 1305
Pharmacopeial Forum: Volume No. 36(3) Page 702