Name of the ingredient
Hydroxycitrate complex (AAN)
Definition of the ingredient
Hydroxycitrate complex is derived from the fruit rind of Garcinia quaesita Pierre or Garcinia zeylanica Roxb. It contains one or more of the three salts (calcium, potassium or sodium) of hydroxycitric acid. Varying amounts of plant material from G. quaesita or G. zeylanica may still be present in the substance depending on the manufacturing process employed, but should not exceed 10% of the final preparation.
This compositional guideline is applicable to each of the salts of hydroxycitric acid as defined above and also applies to mixtures of the above salts.
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Cream to white colour powder |
| Characteristics | ||
| Loss on drying | USP <921> Method III | Not more than 10% |
| Identification | ||
| Hydroxycitric acid | TLC or HPLC | Complies with authenticated reference material |
| Calcium and/or | AAS or ICP-MS* | Complies with authenticated reference material |
| Potassium and/or | ||
| Sodium and/or | ||
| Specific optical rotation | BP Appendix V F. Determination of optical rotation and specific optical rotation | -10° to -20° |
| Assay | ||
| hydroxycitric acid | HPLC | Not less than 50% by wt hydroxycitric acid |
| lactone of hydroxycitric acid | HPLC | Not more than 20% by wt lactone of hydroxycitric acid |
| citric acid | HPLC | Not more than 10% by wt citric acid |
| Notes | ||
| *only tested if present | ||
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Solvent residues | BP (Vol IV, Appendix VIII L Residual solvents; Ph Eur method 2.4.24) | Complies |
| Incidental metals and non-metals | ||
| Lead | BP (Vol IV, Appendix VII Limit test for heavy metals; Ph Eur method 2.4.8) | Not more than 20 ppm |
| Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) | ||
| Pesticide residues | BP (Vol IV, Appendix XI L, Pesticide residues; Ph Eur method 2.8.13) | Complies |
| Microbiology | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
| Notes | ||
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Key to abbreviations
AAS = Atomic absorption spectroscopy
BP = British Pharmacopoeia
HPLC = High-pressure liquid chromatography
ICP-MS = Inductively coupled plasma-mass spectrometry
Ph Eur = European Pharmacopoeia
TLC = Thin layer chromatography
USP = United States Pharmacopoeia