Compositional guideline: Hydroxycitrate complex
Definition of substance
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 hydroxycitrate) 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, .
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.
Specifications
| Test | Limits | Method |
|---|---|---|
| Appearance | Cream to white colour powder | Visual |
| Identification |
Positive Calcium |
TLC or HPLC AAS or ICP-MS* |
| Assay |
NLT 50% by weight hydroxycitric acid NMT 20% by weight lactone of hydroxycitric acid NMT 10% by weight citric acid |
HPLC HPLC HPLC |
| Specific optical rotation | -10° to -20° | BP Appendix V F. Determination of optical rotation and specific optical rotation |
| Moisture | NMT 10% | USP <921> Method III |
| Heavy metals | NMT 20 ppm (expressed as Pb) |
BP limit test |
| Microbiology | Complies | TGAL Guidelines for Assessing the Results of Microbiological Tests on Non-Sterile Pharmaceuticals for Human Use |
| Pesticide residues | Complies | BP |
| Residual solvents | Complies | BP |
Key to abbreviations:
- TLC = thin layer chromatography
- HPLC = high pressure liquid chromatography
- AAS = atomic absorption spectroscopy
- ICP-MS = inductively coupled plasma - mass spectrometry
- NLT = not less than
- NMT = not more than
- BP = British Pharmacopoeia
- USP = United States Pharmacopoeia
- TGAL = TGA Laboratories
- * = only tested if present
Important Note - Labels must declare the amount of hydroxycitrate complex, and the equivalent amount of hydroxycitric acid that is present. In the case of sodium hydroxycitrate, the amount of sodium should be declared where the total sodium content of the formulation is greater than 120 mg of sodium per maximum recommended daily dose (refer to Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>).