The stability of dietary supplements is one of the key elements of their quality. Consumers expect that the declared content of active ingredients will be maintained throughout the shelf life and that the product will be safe and comply with the specifications. To guarantee this, manufacturers use stability studies to assess how a supplement behaves over time, in different climatic conditions and at different temperatures and humidity levels.
At J.S. Hamilton laboratories, we support companies in implementing comprehensive stability testing programs that comply with international guidelines and market requirements.
Why is it worth conducting stability studies?
The active ingredients in supplements — vitamins, minerals, plant extracts, probiotics, fatty acids, and enzymes — can degrade as a result of:
- temperature,
- humidity,
- exposure to light,
- oxidation,
- interactions between ingredients.
The lack of stability testing can lead to:
- loss of potency of active ingredients,
- changes in color, smell, texture,
- delamination of capsules or tablets,
- reduced microbiological safety,
- risk of complaints and batch recalls.
Storage studies in different climate zones
The world has been divided into climate zones according to ICH guidelines. Supplements sold globally should be evaluated under conditions representative of specific regions:
Zone I – temperate climate (e.g., Northern Europe)
Long-term conditions: approx. 21°C / 45–55% RH Application: most products sold in the EU.
Zone II – subtropical and Mediterranean climate (e.g., Southern Europe)
Long-term conditions: 25°C / 60% RH Risk: accelerated degradation of vitamins and extracts.
Zone III – hot and dry climate
Long-term conditions: 30°C / 35% RH Risk: intense drying and oxidation of ingredients.
Zone IV – hot and humid climate (South Asia, Latin America)
Long-term conditions: 30°C / 65–75% RH Greatest risk: degradation of active ingredients, growth of microorganisms, destabilization of soft and hard capsules.
How are stability studies conducted at J.S. Hamilton?
We offer both long-term and accelerated stability studies, performed in accordance with current guidelines.
- Study design
- Analysis of the formulation and form (tablets, capsules, sachets, liquids, oils)
- selection of appropriate climate zones,
- determination of the range of parameters to be monitored.
- Storage in climate chambers
Controlled temperature and humidity, in accordance with ICH standards.
- Periodic analyses
We test, among other things:
- active ingredient content (vitamins, minerals, extracts),
- physicochemical parameters,
- microbiological stability,
- organoleptic characteristics,
- the performance of capsules and tablets in disintegration tests.
- Final report
The manufacturer receives full information about the shelf life of the product, its behavior over time, and recommendations regarding packaging and the declared expiration date.
What does the manufacturer gain?
- Confidence that the declared content of ingredients is maintained,
- Safe shelf life,
- Proof of compliance with EU and foreign market requirements,
- Support with product registration and audits,
- Reduced risk of complaints and financial losses.
Storage tests are an essential part of quality control for dietary supplements. They allow you to determine how long a product remains stable and safe — both on the European market and in various, more demanding climatic zones.
If your supplement is to be launched on the international market or you need to confirm its shelf life, J.S. Hamilton laboratories will prepare a complete stability testing program for you — tailored to the formulation, product type, and target market.