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HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products selected represent those commonly sold and/or available nationally in the U.S. ConsumerLab.com purchased products on the open market through retail stores, on-line retailers, and direct sales or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Method:
SAMe products were tested for their levels of the S-adenosyl-methionine (SAMe). As the molecule can break down under certain circumstances, products were also tested for levels of breakdown products [adenine, s-adenosyl-L-homocysteine (SAH), and methylthioadenosine (MTA)].
SAMe products were analyzed using a Capillary Electrophoresis (CE) or by a high performance liquid chromatography (HPLC) assay.
Disintegration of enteric-coated formulations were analyzed utilizing USP (United States Pharmacopeia) <701> recommendations.
ConsumerLab.com may modify or use other appropriate test methods if necessary to test special product formulations.
All tests were conducted by independent laboratories to which the identities of the products were not disclosed.
Any product not passing an initial analysis was retested in a second independent laboratory on the criteria using similar methods and instrumentation..
Passing Score: *
To pass testing, a product must meet the following criteria:
- Contain its claimed amount of SAMe and no more than 110% of that amount. The amount of "free" SAMe (i.e., not including stabilizing compounds) had to be clearly and accurately stated in the label. Total SAMe degradation products (combined levels of adenine, S-adenosyl-L-homocysteine (SAH) and methylthioadenosine (MTA)) could not exceed 10% of the claimed amount of "free" SAMe.
- Meet recommended USP parameters for disintegration for enteric-coated tablets and dietary supplements (excluding capsule and chewable products).
- Meet FDA labeling requirements.
A "Pass" was based on meeting the above criteria in either the first or second rounds of testing.
* Passing scores allow for specific margins of technical error associated with each analysis. ConsumerLab.com reserves the right to disqualify a product at any time from passing its testing if it considers such product to present a safety risk or to provide misleading or inaccurate information in its labeling.
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