Food Grade (FG)
Antares Vitamin E TPGS Food Grade (FG) complies with Current Good Manufacturing Practices (cGMP) requirements outlined in FDA 21 CFR Part 110 for Foods and FDA CFR 21 Part 111 for dietary supplements. 

Pharmaceutical Grade (NF)
Antares Vitamin E TPGS Pharmaceutical Grade (NF) complies with Current Good Manufacturing Practices (cGMP) requirements outlined in FDA 21 CFR Part 210 for pharmaceuticals. Antares Vitamin E TPGS NF also meets the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG) manufacturing guidelines for pharmaceutical excipients.

Sunflower TPGS™ Non-GMO Grade (NF and FG)
In addition to the quality standards maintained for regular TPGS, the d-α-tocopheryl succinate used in Antares Sunflower TPGS™ contains d-α-tocopherol which is derived exclusively from sunflower which has not been genetically modified. Antares does not use d-α-tocopheryl succinate from d-α-tocopherol derived from genetically modified vegetable sources such as soybean and corn oil in the manufacture of any Sunflower TPGS™.

Food Grade (FG), Pharmaceutical Grade (NF), and Sunflower TPGS™ Non-GMO Grades (NF and FG)

• Raw materials meet applicable specifications and standards and are certified and released by Quality Assurance prior to manufacturing

• Meets Kosher requirements. See Kosher Certificate.

• Meets Halal requirements. See Halal Certificate.

• Utilize ingredients free of BSE/TSE (Bovine Spongiform Encephalopathy / Transmittable Agents of Animal Spongiform Encephalopathy). See BSE/TSE Statement. TSE GMP.

• Utilize ingredients free from and / or process removes known allergens. See Allergen Statement.

• For regular TPGS (FG and NF) the manufacturing process removes compounds (such as proteins) that may be changed by genetic modification. See GMO Statement. 

• Product testing is completed by third party, fully accredited laboratories. Production lots are tested according to the specifications and standards required by their labeling. 

Distribution Practices

International Pharmaceutical Excipients Council (IPEC) IPEC Good Distribution Practices ( IPEC-GDP)

Packaging

Antares Vitamin E TPGS FG, NF, and Sunflower TPGS™ (FG and NF) are all available in 500g, 1 kg, 5 kg and 15 kg tamper-evident sealed HDPE containers. The containers are heat tolerant up to 70 °C.  

Storage and Shelf Life

TPGS should be stored in closed containers at cool, dry temperatures. All Antares Vitamin E TPGS products are labeled with a 4 year shelf life from the date of manufacture when stored at ambient temperature and humidity in the original, sealed, unopened container.