DRAFT AOAC SMPR 2014.XXX; Version 4.1, July 21, 2014
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Method Name:
Screening Method for Selected Adulterants in Dietary
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Ingredients and Supplements Containing Chondroitin Sulfate
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Purpose:
AOAC SMPR’s describe the minimum recommended performance characteristics to be
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used during the evaluation of a method. The evaluation may be an on-site verification, a single-
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laboratory validation, or a multi-site collaborative study. SMPRs are written and adopted by
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AOAC Stakeholder Panels composed of representatives from the industry, regulatory
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organizations, contract laboratories, test kit manufacturers, and academic institutions. AOAC
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SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study data for
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method being considered for
Performance Tested Methods
or AOAC
Official Methods of
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Analysis
, and can be used as acceptance criteria for verification at user laboratories.
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Approved by
: Stakeholder Panel on Dietary Supplements (SPDS)
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Final version date:
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Effective date:
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Intended Use
: Routine surveillance of dietary ingredients and products by a trained
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technician.
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1.
Applicability:
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Screening method for selected adulterants (as identified in Annex I: Target Compounds) in
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dietary ingredients and supplements claiming to contain chondroitin sulfate.
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2.
Analytical Technique:
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Any analytical technique(s) that detects the analytes of interest and meets the following
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method performance requirements is/are acceptable. It is acceptable to have a different
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analytical method for each class of analytes.
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3.
Definitions:
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Adulterant
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Any poisonous or deleterious substance which may render a product injurious to users
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under the conditions of use prescribed in the labeling thereof; or any valuable constituent
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that has been in whole or in part omitted or abstracted; or any substance that has been
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substituted wholly or in part; or a substance that has been added so as to increase the bulk
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or weight, or reduce the quality or strength, or make a product appear better or of greater
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value than it is.
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Chondroitin Sulfate (CS)
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Chondroitin Sulfate Sodium consists mostly of the sodium salt of the sulfate ester of N-
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acetylgalactosamine (2-acetamido-2-deoxy--d-galactopyranose usually abbreviated as
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GalNAc) and d-glucuronic acid copolymer. These hexoses are alternately linked -1,4 and -1,3
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in the polymer. It is closely related to other GAGs such as dermatan sulfate, hyaluronic acid,
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heparin, heparan sulfate, and keratan sulfate which contain other hexosamine and/or
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glycuronic acid residues. Either of the residues can be sulfated at different positions.
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Paraphrase of 21 CFRA
§ 351.
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