“Given that chondroitin is historically prone to adulteration as a popular yet relatively expensive ingredient, getting the right test methods universally accepted and implemented is gravely important,” said Weiguo Zhang, President of Synutra Pure, Ltd, the parent company of Synutra Ingredients.
“As the body of science showing the health benefits of chondroitin grows and fuels increased demand, it is crucial that people buying and taking it are getting only pure chondroitin that will deliver the benefits they expect and deserve.”
Boosting quality standards
Synutra, the leading chondroitin supplier in the US, has been driving efforts to educate the industry about new adulterants in chondroitin and to boost quality standards for the ingredient. The company previously convened a team of industry and analytical experts to identify an adulterant in chondroitin sulfate previously detected by internal work by the company.
In addition to identifying the adulterant as sodium hexametaphosphate, or Calgon, the team also developed a method to test the ingredient. The most commonly used chondroitin assay method, cetylpyridinium chloride (CPC) titration, can be fooled by various known adulterants. Utilizing cellulose acetate membrane electrophoresis (CAME) before CPC can weed out any adulterated product, however.
CAME, which has been in the USP monograph for chondroitin sulfate for years, is an inexpensive (as little as $190 per sample), simple, and effective procedure that can be used as a qualitative raw material screening tool before running quantitative methods such as CPC or other specific methods such as enzymatic HPLC.
eHPLC – yes; CAME – not yet.
The AOAC’s Expert Review Panel for chondroitin assessed four methods at the ERP meeting in August, Jana Hildreth, Synutra Pure’s Director of Technology and Scientific Affair told us.
“Upon ERP review and discussions, the only one that was recommended for first action was the eHPLC method,” she said. First Action Status means fit-for-purpose methods reviewed and approved by an AOAC expert review panel or method committee based on evaluation against standard method performance requirements or studies conducted.
“CAME was not recommended to move on to first action but did receive a second motion that the method author supply additional data to see if the method meets the chondroitin working group's SMPR (Standard Method Performance Requirements) for detection of adulterants in chondroitin,” she added.
“The other two methods used either equipment that was not routine to manufacturing and contract labs and/or not enough data or historical use to show that they would be good candidates for becoming ‘Official Methods’. The next step for the eHPLC method is to have a lab incorporate the suggestions outlined by the ERP.”
Ongoing education
Synutra Ingredients is also continuing its campaign to gain consensus on effective chondroitin testing methods to detect and deter adulterants, with a poster to be presented at the upcoming 129th AOAC International Annual Meeting to be held in Los Angeles CA on September 27 to 30, 2015. The poster was authored by Weiguo Zhang, Jana Hildreth, and Dr Volpi from University of Modena and Reggio Emilia, Italy and Drs. Hellen Oketch and Huy Dinh from the United States Pharmacopeia.
Hildreth will also take part in a session titled “Analytical Roundtable for Regulated: Analytical Laboratories and the Dietary Supplements cGMP Challenge” that will take place on September 30th from 10:15-11:45am. For more information please click HERE.
Hildreth will also present at the 2015 International Nutrition and Diagnostics Conference to be held in Prague, Czech Republic, from October 5th-8th Jana on the topic “Best Practices on Chondroitin Quality in a Globalized Supply Chain: Quality Regimes, Standards and Methodologies”.