The stability of dietary supplements is a fundamental aspect of their quality. Consumers expect the stated levels of active ingredients to remain consistent throughout the product’s shelf life and that the product remains safe and compliant with established specifications. To guarantee this, manufacturers use stability studies to evaluate how the supplement behaves over time, in different climates – at different temperatures and humidity levels.
The active ingredients in supplements — vitamins, minerals, herbal extracts, probiotics, fatty acids and enzymes — can degrade as a result of:
• temperature
• humidity
• exposure to light
• oxidation
• interaction between ingredients.
These processes may lead to:
• reduction of the concentration of active ingredients
• changes in color, smell, texture
• delamination of capsules or tablets
• reduced microbiological safety
• risk of complaints and batch recalls.
Nutritional supplements intended for the global market should be tested in conditions that correspond to the specificities of individual regions – climatic zones, in accordance with the guidelines of the International Council for Harmonization (ICH):
Zone I – moderate climate (e.g. Northern Europe)
Long-term conditions: approximately 21°C / 45–55% relative humidity.
Application: most products sold in the EU.
Zone II – subtropical and Mediterranean climate (e.g. Southern Europe)
Long-term conditions: 25°C / 60% relative humidity.
Risk: accelerated degradation of vitamins and extracts.
Zone III – hot and dry climate.
Long-term conditions: 30°C / 35% relative humidity.
Risk: intense loss of moisture and oxidation of ingredients.
Zone IV – warm and humid climate (South Asia, Latin America).
Long-term conditions: 30°C / 65–75% relative humidity.
Greatest risk: degradation of active ingredients, growth of microorganisms, destabilization of soft and hard capsules.
Long-term and accelerated stability studies are available to customers, which are performed in accordance with current guidelines.
1. Study design
• analysis of formulation and form (tablets, capsules, sachets, liquids, oils)
• selection of appropriate climate zones
• determining the parameters to be monitored.
2. Storage in climatic chambers
Controlled temperature and humidity, in accordance with ICH standards.
3. Periodic analyses
Testings include, among others:
• content of active ingredients (vitamins, minerals, extracts)
• physical-chemical parameters
• microbiological stability
• organoleptic characteristics
• performance of capsules and tablets in disintegration tests (tests that check how quickly a tablet, capsule or other form of supplement disintegrates after ingestion)
4. Report
Upon completion of the study the manufacturer receives all relevant information about the shelf life of the product, its stability over time, as well as recommendations regarding the choice of packaging and labeling of the expiration date.
• confirmation that the declared content of ingredients is maintained
• safe shelf life
• proof of compliance with the regulatory requirements of the EU and the market where the product is marketed
• support for product registration and audits
• reduced risk of complaints and financial losses.
Storage tests are an essential part of quality control of dietary supplements. It allows to determine how long the product remains stable and safe — both on the European market and in different, more demanding climate zones.
If your product needs to be placed on the international market or you need to confirm its shelf life, J.S. Hamilton can prepare a complete stability testing program — tailored to the formulation, product type and target market.
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