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Shark cartilage derived Chondroitin
PO Box 100 Woden ACT 2606 Australia
Telephone: (02) 6232 8444 Facsimile: (02) 6232 8241
Draft Compositional Guideline - Shark cartilage derived Chondroitin Sulfate
Shark cartilage derived chondroitin sulfate powder, intended for use in encapsulated, tabletted or powdered nutritional supplements, comprises predominantly the glycosaminoglycan chondroitin-6-sulfate, but also a lesser, variable proportion of chondroitin-4-sulfate and dermatan sulfate. Small amounts of other glycosaminoglycans (GAGs), protein and calcium may be present. The product may be combined with a flow agent to assist in encapsulation or tabletting.
Specifications for chondriotin sulfate derived from shark cartilage
Table 2: Draft Compositional Guideline - Shark derived chondroitin sulfate
*Not prescribed: The method must be able to discriminate between CS and other GAGs SEC-HPLC analysis1: Volpi N and Bolagnani L (1993) Journal of Chromatography 630:390-396
UV methods2: Dye-based GAG analysis (Farridale RW, Buttle DJ and Barrett AJ 1986
Biochimica Biophysica Acta 883:173-177) following specific precipitation of non-CS
GAGs (Volpi N 1996 Journal of Chromatography B 685: 27-34)
Electrophoresis3: Volpi N (1999) Analytical Biochemistry 273:229-239
You are invited to make a written submission containing technical or other relevant information that may assist the TGA in the development of Compositional Guidelines.
Information relevant to the Compositional Guideline above, including consideration of its regulatory impact, from individuals and organisations, would contribute to the decision making process. Technical information should be presented in sufficient detail to allow independent scientific review.
If you wish any confidential information contained in a submission to remain confidential to the TGA, you should clearly identify the sensitive information and provide justification for treating it in confidence.
Address for submissions:
Office of Complementary Medicines, TGA
PO Box 100
WODEN ACT 2606
Fax: (02) 6232 8577
Submissions must be received by close of business 25 August 2000.
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