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Residual Solvents

Residual Solvents are defined as organic volatile chemicals used or produced in the manufacturing of dietary ingredients or dietary supplement products.  Since residual solvents do not provide therapeutic benefit, they should be removed, to the extent possible. USP 467 Residual Solvents defines the limits for compliance.

Classifications:

  • Class 1 solvents are to be avoided and are known human carcinogens or strongly suspected human carcinogens.  And they are known to have ozone-depleting properties.
  • Class 2 solvents are to be limited and are possible causative agents to irreversible toxicity or suspected of other significant or reversible toxicities.
  • Class 3 solvents have low toxic potential and have no health-based exposure limits.
  • The limits for Class 2 solvents are based on toxicological permitted daily exposure.
  • The limits for Class 3 solvents are considered less toxic and control to 50 mg/day or less is acceptable without justification.
  • Testing for Class 1 and Class 2 solvents is performed at Exact Scientific Services, Inc on by Gas Chromatography with a Flame ionization detector. The Injector is headspace.

Click here for our list of solvents.

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