Monograph: Borage Oil

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: (i) Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) Vitamin E is an optional medicinal ingredient in borage oil products. However, no use or purpose statements may be associated with vitamin E. See Appendix 1 for vitamin E proper name, common name, source material, and dose information.
Date: 2018-09-25

NHPID name

Borago Officinalis Seed Oil ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Common name(s)

Borage Oil

Source material

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Dose(s)

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): No statement is required Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Specifications

References cited

References reviewed

Appendix 1: Vitamin E

Proper name(s), common name(s), and source material(s):

Table 1: Vitamin E proper names, common names and source materials
Proper name(s) Common name(s) Source material(s)

Vitamin E (Sweetman 2007; IOM 2003; O’Neil et al. 2001)

Alpha-Tocopherol/α-Tocopherol (Sweetman 2007; O’Neil et al. 2001);

Vitamin E (Sweetman 2007; IOM 2003; O’Neil et al. 2001)

All racemic-α-Tocopherol/all rac-α-Tocopherol/ dl-α-Tocopherol (Sweetman 2007; IOM 2003)

All racemic α-Tocopheryl acetate/all-rac-α-Tocopheryl acetate/ dl-α-Tocopheryl acetate (Sweetman 2007; IOM 2003)

All racemic-α-Tocopheryl succinate/all rac-α-Tocopheryl succinate/ dl-α-Tocopheryl acid succinate/ dl-α-Tocopheryl succinate (Sweetman 2007)

RRR-α-Tocopherol/ d-α-Tocopherol (Sweetman 2007; IOM 2003; O’Neil et al. 2001)

RRR-α-Tocopheryl acetate/ d-α-Tocopheryl
acetate (Sweetman 2007; IOM 2003)

RRR-α-Tocopheryl succinate/ d-α-Tocopheryl acid succinate/ d-α-Tocopheryl succinate (Sweetman 2007; IOM 2003)

Quantity:

The quantity of vitamin E must always be provided in terms of α-Tocopherol (AT) (i.e. mg RRR-α-Tocopherol), irrespective of the source material used.

IUs may be provided as optional additional information on the PLA form in the "potency" field and on product labels.

Table 2: Dose information for vitamin E presented as dose per day (IOM 2006)
Subpopulation Vitamin E (mg AT/day)
Minimum Maximum
Adults ≥ 19 y 4.5 179

 

Conversion factors:

Table 3: Conversion of vitamin E source material quantity into vitamin E quantity in terms of alpha-tocopherol (AT) and vitamin E activity in terms of International Unit (IU) (IOM 2006)
Source material
(1 mg)
Vitamin E quantity
(mg AT)
Vitamin E activity
RRR-α-Tocopherol 1.00 1.49
RRR-α-Tocopheryl acetate 0.91 1.36
RRR-α-Tocopheryl succinate 0.81 1.21
All rac-α-tocopherol 0.50 1.10
All rac-α-tocopheryl acetate 0.46 1.00
All rac-α-tocopheryl succinate 0.41 0.89
Table 4: Conversion of vitamin E source material activity into vitamin E quantity in terms of alpha-tocopherol (AT) (IOM 2006)
Source material
(1 IU)
Vitamin E quantity
(mg AT)
RRR-α-Tocopherol 0.67
RRR-α-Tocopheryl acetate 0.67
RRR-α-Tocopheryl succinate 0.67
All rac-α-tocopherol 0.45
All rac-α-tocopheryl acetate 0.45
All rac-α-tocopheryl succinate 0.45

Examples using the vitamin E conversion factors:

  1. Converting vitamin E activity into quantity of AT (mg)

    Convert 400 IU of RRR-α-tocopheryl succinate activity into mg AT:
    = 400 IU x 0.67 mg AT/IU
    = 268 mg AT
  2. Converting vitamin E source material quantity into quantity of AT (mg)

    Convert 200 mg of all rac-α-tocopheryl acetate into mg AT:
    = 200 mg x 0.46 mg AT/mg
    = 92 mg AT