GLUCOSAMINE SULFATE

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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

March 11, 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 ingredient(s) Source material(s) Organism group(s)1 Part(s) Preparation(s)

2-Amino-2-deoxy-D-glucose sulfate

Glucosamine sulfate
  • Glucosamine Sulfate Potassium Chloride
  • Glucosamine Sulfate Sodium Chloride

N/A
  • Crab
  • Krill
  • Lobster
  • Prawn
  • Shrimp

Exoskeleton

N/A
  • Aspergillus flavus var. oryzae
  • Aspergillus melleus
  • Aspergillus niger
  • Aspergillus niger var. awamori
  • Monascus pilosus
  • Monascus purpureus
  • Rhizopus oryzae

N/A

Whole

Fermented

References: Proper name: NLM 2018; Common name: USP 32 2009, Sweetman 2007, Towheed and Anastassiades 2007; Source information: ITIS 2008, Kralovec and Barrow 2008.

1 The specific organisms used as source material(s) must be indicated in the Animal Tissue Form (ATF); simply indicating "crustaceans" is insufficient.

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:

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

1,500 milligrams of glucosamine sulfate, per day (Herrero-Beaumont et al. 2007; Pavelka et al. 2002; Reginster et al. 2001)

Direction(s) for use

No statement required.

Duration of Use

Use for at least 4 weeks to see beneficial effects (Mehta et al. 2007; Usha and Naidu 2004; Houpt et al. 1999; Qiu et al. 1998).

Risk Information

Caution(s) and Warning(s)

Contraindication(s)

No statement required.

Known Adverse Reaction(s)

No statement required.

Storage Condition(s)

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

Non Medicinal Ingredients

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

Specifications

References Cited

References Reviewed