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Comment 160
Addressed (Unresolved)
173i29.pdf (Revision 0)
Approval of 173i29r1
Comment Submitted by
Allison McCutcheon
2008-02-22 23:17:07
6.2.4 Other dietary supplement ingredients
Should be amended to include quantification based upon bioactivity. For many DS the putative "active ingredients" have not been conclusively idenified, and in these cases quantification based on relevant bioactivity may be superior. In this context "micro-assays" would be better described as micro-chemical assays.

6.2.5.1 Calibration
The term "certified reference materials" (CRMs) has a specific meaning and CRMs are not available for many DS. Suggest deleting the word "certified" or amending the wording to better reflect the intent.


MINOR EDITORIAL QUIBLES

6.2.5.1.4 Reproducibility/accuracy
Define "unfamiliar"?

6.2.1-6.2.4 Listing of other guidelines should be alphabetical, otherwise it implies an order of preference.

6.2.4 Insert word "pharmacopoeial"; I.e The source of these methods may include AOAC International, or AHP, European, German, Japanese, USP-NF etc. pharmacopoeial
monographs.

6.2.5.1.5 Insert space between word acceptable and 80-120%
Submitter Proposed Solution
Developer Response
Good Afternoon Ms. McCutcheon, Thank you for your comments on the Joint Committee ballot of Standard 173 (173i29) regarding the quality assurance for quantitative test methods. Attached are your comments on this issue and the response of the issue proponent, Kerri LeVanseler of NSF International. I hope the above addresses your concerns. Thank you for your comments. If you have additional comments, or wish to discuss these points further, please contact Ms. LeVanseler.
Supporting File: Levanseler-McCutcheon-response 10-14-2008.pdf