The objective of this project is for students to properly assess the stability and shelf life of NeuroActiv Oil™, our patented wide-spectrum fatty acid oil formulation.

NeuroActiv Oil™ is in its final product state ready for distribution and sale. The stability of the product is assessed by determining the Totox Values (< 26 mEq/Kg, see appendix 1 below) as well as the bacterial and mold contamination (see Appendix 1) over a period up to one year. Products will be provided at the appropriate age of the product life for unopened bottles stored at room temperature and humidity conditions. Another series of tests we would like to determine is the Shelf-life of the product once it has been opened and stored at room temperature and humidity conditions.

Timeline:

0 months

3 months

6 months

9 months

12 months

___________________________________________________________________________________________________

Appendix 1. Excerpts from Health Canada: Quality of Natural Health Products Guide

Link to Health Canada: Quality of Natural Health Products Guide

3.3.11 Oxidative stability in oils

Adulterations can occur as a result of poor quality control practices or it can be purposeful in order to use cheaper alternatives or improve product efficacy.

Oxidative stability testing is applicable to all oils that have a high degree of unsaturation to ensure stability. Where oxidative stability tests are required by pharmacopoeial monographs, the tolerance limits as per the appropriate monograph may be used. Testing should be done according to AOAC and/or Pharmacopoeial analytical methods for peroxide, anisidine, and total oxidation (TOTOX) values of marine oils or omega-3 fatty acids derived from marine oils to ensure their oxidative stability.

Table 4: Acceptable limits for oxidative stability parameters in marine oils

Oxidative stability parameter

Acceptable limit

Peroxide value (PV): NMT 5 mEq/Kg

Anisidine value (AV): NMT 20 mEq/Kg

TOTOX value: NMT 26 mEq/Kg calculated as 2 x PV + AV

The above limits are appropriate for the raw materials, but may not be appropriate for the finished product if non-medicinal ingredients interfere with the testing. In these cases the license holder should develop product specific limits that ensure stability of the oil in the finished product.

Microbial impurity testing (finished product stage)

Pharmacopoeial or other internationally recognized test methods.

Total aerobic plate count: 10000 CFU/g or mL

Total yeast and mould count (fungi): 100 CFU/g or mL

Enterobacteriaceae and bile tolerant Gram-negative bacteria: 100 CFU/g or mL

Salmonella spp. : Absent (10g or 10mL)

Escherichia coli: Absent (1g or 1mL)

Staphylococcus aureus: Absent (1g or 1mL)

Pseudomonas aeruginosa: Absent (1g or 1mL)

_____________________________________________________________________________________________________

The final goal of this research is to develop a report of the research conducted indicating laboratory results of the Totox Values ( see Appendix 1 above) as well as the bacterial and mold contamination (see Appendix 1) for opened and unopened bottles of NeuroActiv Oil™ at each of the following intervals:

0 months

3 months

6 months

9 months

12 months

Students are welcome to provide, as a separate document, recommendations related to stability and shelf life based on laboratory results.