Chondroitin Suppliers Exploring USP Testing Protocol
RIVERTON, Utah--A group of chondroitin sulfate (CSA) suppliers and users have submitted a validated testing method using the CPC (Cetyl Pyridinium Chloride) titration procedure to the U.S. Pharmacopeia (USP) for recommended adoption. USP could adopt the standardized testing protocol by mid-2002.
Research to develop the method was funded by members of the Chondroitin Sulfate Science Committee (CSSC), originally organized by the National Nutritional Foods Association (NNFA) and Eurofins Scientific (SupplySide West Booth #1738). Input was given by many companies, including USP (SupplySide West Booth #1100), Weider Nutrition, Shuster Labs, ConsumerLab.com, Technical Sourcing International (SupplySide West Booth #1506), Cargill (SupplySide West Booth #1205), Pharmore Ingredients (SupplySide West Booth #1766) and Bioberica. According to Warren Majerus, vice president of quality and technology at Pharmore (www.PharmoreIngredients.com), the group pinpointed five basic issues that affect the method for accurately determining the potency of CSA. They include material standard used for calibrating test equipment, standard preparation methods, methods and equipment used for testing, sample test reporting format, and a definition of what is "USP grade" material.
Purity of standards is important because inaccurately calibrated testing equipment could show an inaccurate result. "USP has not yet chosen a standard, but will likely test several sources and select the most consistent, highest purity material for its USP standard method protocol," Majerus said. Because CSA absorbs moisture rapidly, it must be dried quickly and thoroughly. The USP testing protocol would define the drying procedure to ensure consistent drying levels and standardized potency determinations.
Majerus reported there are several types of test equipment currently used to determine potency of CSA. "The current USP preferred method is the CPC titration method," Majerus said; he added that USP (www.usp.org) is taking industry comments on the issue. Once material is tested, results can be reported "as is" or "dried." The terms reflect whether the sample is tested and later found to contain moisture, or if it is dried before testing.
Finally, USP is considering what potency should be required to call CSA "USP grade." "Some factions feel that 95 percent or higher material should be required to be labeled USP grade," Majerus said. "Others feel that since the vast majority of suppliers now have difficulty achieving that potency, that 90 percent should be a standard. Confounding the issue is whether the reports will be issued on an 'as is' or 'dried' basis."