IU Values and FDA Specifications for Tocotrienols and Vitamin E

Regarding your inquiry about the Vitamin E units (IU) and specifications for FDA (อย.) submission for the two products, here is the detailed information:

1. Vitamin E (dl-alpha tocopherol) [ID 135]

This is a synthetic form of Vitamin E with high purity.

• IU per Gram: Approximately 1,100 IU/g.
  • Calculation: The conversion factor for synthetic dl-alpha tocopherol is 1.1 IU per 1 mg. Since the product has a concentration (Assay) of at least 96-100%, 1 gram (1,000 mg) provides approximately 1,100 IU.
• Relevant Specifications for FDA:
  • INCI Name: dl-alpha tocopherol
  • CAS Number: 59-02-9
  • Assay: Not less than 96%
  • Appearance: Dark yellow, viscous oil.

2. Tocotrienols (30% Water-Disperse Powder, Food) [ID 10995]

This product is a complex of Tocotrienols and Tocopherols in powder form.

• IU per Gram: Approximately 129.6 IU/g (calculated from the d-alpha-tocopherol content).
  • Note: In regulatory terms, IU (International Units) specifically measures Vitamin E activity based on alpha-tocopherol. Tocotrienols themselves are typically measured in milligrams (mg) rather than IU.
  • Calculation: Based on the typical value of d-alpha-tocopherol at 8.7%: 87 mg x 1.49 IU/mg (natural factor) ≈ 129.6 IU/g.
• Relevant Specifications for FDA:
  • Total Tocotrienols: Minimum 30% (Typical value 32% or 320 mg/g).
  • Composition Breakdown:
    • d-alpha-Tocopherol: ~8.7%
    • d-alpha-Tocotrienol: ~8.9%
    • d-gamma-Tocotrienol: ~10.5%
    • d-delta-Tocotrienol: ~3.1%
    • d-beta-Tocotrienol: ~1.0%
  • Form: Water-disperse powder (suitable for food/supplements).

Recommendation for FDA Submission:
When submitting for FDA (อย.) approval for dietary supplements, it is common to declare the Vitamin E (as d-alpha-tocopherol) in IU and the Tocotrienols in milligrams (mg) separately to clearly show the antioxidant profile of the product. For the pure Vitamin E (ID 135), you can declare the total IU based on the weight used in the formula.