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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, catalogues, or multi-level marketing companies. Products were not accepted directly from manufacturers.
Testing Method:
Products were tested for their amount of specific monacolins, disintegration, and potential contamination with citrinin and lead. Analyses for monacolins and citrinin was performed by HPLC/MS/MS.
Analyses for lead was were performed using ICP-MS (Inductively Coupled Plasma-Mass Spectroscopy) method in an independent laboratory.
Disintegration of non-chewable, non-capsule, non-enteric coated and non-time-release formulations were analyzed utilizing USP (United States Pharmacopeia) <2040> recommendations.
All tests for key ingredients and contaminants were conducted by independent laboratories to which the identities of the products were not disclosed.
Review Criteria:
- Product expected to meet label claims concerning monacolins and citrinin. Total monacolins was equal to the sum of: monacolin J, monacolin JA, monacolin K (lovastatin), monacolin KA (hydroxy acid lovastatin), monacolin L, monacolin LA, monacolin M, monacolin X, monacolin XA, dihydromonacolin K (DMK), hydroxy dihydromonacolin L (HDML), and monacolin M acid (MMA).
- Meet recommended USP parameters for disintegration for dietary supplements (excluding capsule, enteric coated, chewable and time-release products).
- Not exceed California Prop 65 levels for lead contamination in a recommended daily serving, i.e., contain less than 0.5 mcg of lead per daily serving with an additional allowance of 1.0 mcg for supplements containing 1,000 mg/day or more of elemental calcium and 0.5 mcg for supplements containing specific other minerals.** For supplements not marketed for use by children, ConsumerLab.com provides an additional allowance of 0.5 mcg if containing 250 to 499 mg/day of elemental calcium, or 1.0 mcg if containing 500 to 999 mg/day of elemental calcium, and an allowance of 0.5 mcg if containing one whole herb (not extract) ingredient or 1.0 mcg for two or more whole herb ingredients. If a maximum recommended daily serving is not defined, a daily serving size will be determined and applied by CL.
- Meet FDA labeling requirements.
*The criteria 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.
**If available for sale in California, a product that exceeds the State of California's Prop 65 lead limit requires a warning label. However, with or without this warning label, products cannot be pass ConsumerLab.com testing if they exceed the levels described in paragraph above.
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