Maintaining the quality of supplements through stability testing

The dietary supplement market has grown substantially over the past 20 years, in terms of both sales and the number of products available1.

 

This trend has been primarily driven by increased consumer focus on personal health and wellbeing, with supplements being developed to support chronic disease management, weight loss, nutrition, and brain health 1, 2 As the industry continues to grow and becomes increasingly competitive, ensuring supplement quality and compliance is more important than ever. 

 

 As a result, it is vital that quality is prioritised throughout the entire supplement development process. To support this goal, a crucial stage is stability testing, which assesses a product’s integrity and performance over the course of its shelf life. Ensuring supplement stability is critical for meeting the quality, safety, and efficacy expectations of consumers and regulatory bodies, so accurate and precise testing should form a core component of any development project. 

What is supplement stability testing?

 

Manufacturers are responsible for ensuring that the labelled expiry date of their food products are accurate. Thorough stability testing helps to ensure that the necessary safety and efficacy requirements are met for all ingredients throughout a product’s shelf life. It also helps ensure there are no undesirable changes to sensorial properties such as texture, colour, flavour, or odour 3.

 

This is particularly important for supplements, which typically contain multiple active ingredients, each with unique stability requirements. Different ingredients break down at different rates, so the labelled shelf life must be based on the ingredient with the fastest decline. Moreover, in complex formulations such as dietary supplements, the different constituent ingredients can react with each other, further impacting stability.

To quantify ingredient levels and ensure accuracy in both real-time and accelerated shelf life studies, tailored analytical methods are essential. In order to minimise analytical variation, the methods used should be specific, accurate, and repeatable for the active ingredient in relation to the product matrix. For products containing multiple ingredients, several assays may be required.

What tests are conducted during a stability study?

 

There are a number of different tests that can be performed as part of the stability study, including organoleptic, physical, microbiological, and chemical analyses.

 

All claimed component levels need to be determined using appropriate analytical methods, but in complex matrices it may be acceptable to test for the less stable ingredients and extrapolate using a risk-based approach.

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