SOY FLOUR

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

September 29, 2022

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation

Glycine max

  • Soybean Flour
  • Soy Flour

Glycine max

Seed

Dry

  • Defatted soybean flour1
  • Defatted soy flour1

Glycine max

Seed

Dry

References: Proper name: USDA 2019; Common names: USDA 2019, Tomar and Shiao 2008; Source information: USDA 2019, Tomar and Shiao 2008.

1Defatted flour refers to preparations where the oil has been removed.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

Source of (an) essential amino acid(s) involved in muscle protein synthesis and for the maintenance of good health (IOM 2005).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidants

Methods of preparation: Powder; Defatted, ground

Not to exceed 8 grams of soy flour and/or defatted soy flour, per day (Tomar and Shiao 2008; Travis et al. 2008).

Source of Protein

Method of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Note: If soy flour and defatted soy flour are combined, 7.5 grams should be used as the minimum total daily dose and 8 grams as the maximum total daily dose.

Source of (essential) amino acid(s) involved in muscle protein synthesis/for the maintenance of good health

Method of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Note: If soy flour and defatted soy flour are combined, 7.5 grams should be used as the minimum total daily dose and 8 grams as the maximum total daily dose.

OR

Method of preparation: Standardized Powder

Essential amino acids Minimum dose of amino acid (milligrams/day)1 Maximum dose of Soy flour and/or Defatted soy flour (grams/day)2

Histidine

49 mg

8 g

Isoleucine

66.5 mg

Leucine

147 mg

Lysine

133 mg

Methionine

66.5 mg

Phenylalanine

115.5 mg

Threonine

70 mg

Tryptophan

17.5 mg

Valine

84 mg

1Minimum doses have been calculated as 5% of each specific amino acid Recommended Dietary Allowance with a reference weight of 70 kg (IOM 2005).

2Maximum dose (CNF 2015; Tomar and Shiao 2008; Travis et al. 2008; IOM 2005).

Source of (non-essential) amino acids involved in muscle protein synthesis

Method of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Note: If soy flour and defatted soy flour are combined, 7.5 grams should be used as the minimum total daily dose and 8 grams as the maximum total daily dose.

OR

Method of preparation: Standardized Powder

Non-Essential amino acids Minimum dose of amino acid (milligrams/day)1 Maximum dose of Soy flour and/or Defatted soy flour (grams/day)2

Alanine

181.5 mg

8 g

Arginine

208.5 mg

Aspartic acid

325 mg

Glutamic acid

750 mg

Glycine

160 mg

Proline

259.5 mg

Serine

175.5 mg

Tyrosine

139 mg

1Minimum doses have been calculated as 5% of each specific amino acid Mean Intake with a reference weight of 70 kg (IOM 2005).

2Maximum dose (CNF 2015; Tomar and Shiao 2008; Travis et al. 2008; IOM 2005).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

No statement required.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

References Cited

References Reviewed