PHOSPHATIDYLSERINE

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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

July 1, 2019

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

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

Phosphatidylserine

Phosphatidylserine

N/A

Helianthus annuus

Seed

Isolate

Phosphatidylserine-enriched soy lecithin

N/A

N/A

N/A

Phosphatidylserine

N/A

N/A

Synthetic

References: Proper name: NIH 2009; Common name: NIH 2009; Source information: USFDA 2006, USFDA 2003.

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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Helps support cognitive health and/or brain function (Schreiber et al. 2000; Cenacchi et al.1993; Crook et al. 1992; Engel et al. 1992; Crook et al.1991; Maggioni et al. 1990).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

300 milligrams of Phosphatidylserine, per day (Schreiber et al. 2000; Cenacchi et al.1993; Crook et al. 1992; Engel et al. 1992; Crook et al.1991; Maggioni et al. 1990).

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

No statement required.

Specifications

References Cited

References Reviewed