FDA Laboratory Testing Company

Polyhedron Laboratories performs U.S. Food and Drug Administration (FDA) testing to CFR standards; a list of these tests are given below:

  • FDA-CFR-177.1310, Extractions in Stainless Steel Cells in a High Pressure Reactor/2 hours
  • FDA-CFR-176.170 Water Extractables 250 Degrees Fahrenheit/2 hours
  • FDA-CFR-176.170 Heptane Extractables 150 Degrees Fahrenheit/2 hours
  • FDA-CFR-176.170 Heptane Soluble Extractables
  • FDA-CFR-176.170 Water Soluble Extractables
  • FDA-CFR-176.170 8% Alcohol Extractables
  • FDA-CFR-176.170 50% Alcohol Extractables
  • FDA-CFR-177.1520 % Hexane Extractables at 50 Degrees Centigrade
  • FDA-CFR.177.1520 % Xylene Extractables at 25 Degrees Centigrade
FDA Extraction by ASTM D 4754 (at 160 Degrees Fahrenheit/2 hours) ASTM D 4754-98 - Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
This test procedure outlines the use of the FDA migration cell in the extraction of components and permits quantitation of individual migrants from plastic materials by appropriate extracting of liquids, including food-stimulating solvents and liquid foods. This test routine allows for a two-sided, liquid extraction test for plastic materials that can be formed into disks, sheet, or film. Additionally, this test procedure has been applied to a variety of migrant/polymer systems in contact with numerous food stimulants and foods. This test routine has been shown to yield reproducible results under the conditions for migration tests requested by the FDA.

Additional testing performed by Polyhedron includes % Hexane Extractables by Soxhlet Extraction (24 hours), and % Heptane Extractables by Soxhlet Extraction (24 hours).

% Hexane Extractables by Soxhlet Extraction 24 hrs
FDA Extraction by ASTM D 4754 at 160°F/2 hrs.
FDA-CFR-177.1310 Extractions in Stainless Steel Cells in a High Pressure Reactor /2 hrs.
FDA-CFR-176.170 Water Extractables 250°F/2 hrs.
FDA-CFR-176.170 Heptane Extractables 150°F/2 hrs.
FDA-CFR-176.170 Heptane Soluble Extractables
FDA-CFR-176.170 Water Soluble Extractables
FDA-CFR-176.170 8% Alcohol Extractables
FDA-CFR-176.170 50% Alcohol Extractables
FDA-CFR-177.1520 % Hexane Extractables at 50°C
FDA-CFR-177.1520 % Xylene Extractables at 25°C