{"id":5270,"date":"2026-05-04T11:47:01","date_gmt":"2026-05-04T09:47:01","guid":{"rendered":"https:\/\/splaboratorija.rs\/?p=5270"},"modified":"2026-05-04T11:50:29","modified_gmt":"2026-05-04T09:50:29","slug":"storage-testing-of-dietary-supplements-how-long-the-product-retains-its-characteristics-in-different-climatic-conditions","status":"publish","type":"post","link":"https:\/\/splaboratorija.rs\/en\/2026\/05\/04\/storage-testing-of-dietary-supplements-how-long-the-product-retains-its-characteristics-in-different-climatic-conditions\/","title":{"rendered":"Storage testing of dietary supplements \u00a0– how long the product retains its characteristics in different climatic conditions"},"content":{"rendered":"\n

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\u2019s 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.<\/p>\n\n\n\n

Why is it useful to conduct stability studies?<\/strong><\/h2>\n\n\n\n

The active ingredients in supplements \u2014 vitamins, minerals, herbal extracts, probiotics, fatty acids and enzymes \u2014 can degrade as a result of:<\/p>\n\n\n\n

\u2022 temperature<\/p>\n\n\n\n

\u2022 humidity<\/p>\n\n\n\n

\u2022 exposure to light<\/p>\n\n\n\n

\u2022 oxidation<\/p>\n\n\n\n

\u2022 interaction between ingredients.<\/p>\n\n\n\n

These processes may lead to:<\/p>\n\n\n\n

\u2022 reduction of the concentration of active ingredients<\/p>\n\n\n\n

\u2022 changes in color, smell, texture<\/p>\n\n\n\n

\u2022 delamination of capsules or tablets<\/p>\n\n\n\n

\u2022 reduced microbiological safety<\/p>\n\n\n\n

\u2022 risk of complaints and batch recalls.<\/p>\n\n\n

\n
\"\"<\/figure>\n<\/div>\n\n\n

Stability studies in different climate zones<\/strong><\/h2>\n\n\n\n

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):<\/p>\n\n\n\n

Zone I \u2013 moderate climate (e.g. Northern Europe)<\/p>\n\n\n\n

Long-term conditions: approximately 21\u00b0C \/ 45\u201355% relative humidity.<\/p>\n\n\n\n

Application: most products sold in the EU.<\/p>\n\n\n\n

Zone II \u2013 subtropical and Mediterranean climate (e.g. Southern Europe)<\/p>\n\n\n\n

Long-term conditions: 25\u00b0C \/ 60% relative humidity.<\/p>\n\n\n\n

Risk: accelerated degradation of vitamins and extracts.<\/p>\n\n\n\n

Zone III \u2013 hot and dry climate.<\/p>\n\n\n\n

Long-term conditions: 30\u00b0C \/ 35% relative humidity.<\/p>\n\n\n\n

Risk: intense loss of moisture and oxidation of ingredients.<\/p>\n\n\n\n

Zone IV \u2013 warm and humid climate (South Asia, Latin America).<\/p>\n\n\n\n

Long-term conditions: 30\u00b0C \/ 65\u201375% relative humidity.<\/p>\n\n\n\n

Greatest risk: degradation of active ingredients, growth of microorganisms, destabilization of soft and hard capsules.<\/p>\n\n\n\n

How are stability studies conducted at J.S. Hamilton?<\/strong><\/h2>\n\n\n\n

Long-term and accelerated stability studies are available to customers, which are performed in accordance with current guidelines.<\/p>\n\n\n\n

1. Study design<\/strong><\/p>\n\n\n\n

\u2022 analysis of formulation and form (tablets, capsules, sachets, liquids, oils)<\/p>\n\n\n\n

\u2022 selection of appropriate climate zones<\/p>\n\n\n\n

\u2022 determining the parameters to be monitored.<\/p>\n\n\n\n

2. Storage in climatic chambers<\/strong><\/p>\n\n\n\n

Controlled temperature and humidity, in accordance with ICH standards.<\/p>\n\n\n\n

3. Periodic analyses<\/strong><\/p>\n\n\n\n

Testings include, among others:<\/p>\n\n\n\n

\u2022 content of active ingredients (vitamins, minerals, extracts)<\/p>\n\n\n\n

\u2022 physical-chemical parameters<\/p>\n\n\n\n

\u2022 microbiological stability<\/p>\n\n\n\n

\u2022 organoleptic characteristics<\/p>\n\n\n\n

\u2022 performance of capsules and tablets in disintegration tests (tests that check how quickly a tablet, capsule or other form of supplement disintegrates after ingestion)<\/p>\n\n\n\n

4. Report<\/strong><\/p>\n\n\n\n

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.<\/p>\n\n\n\n

What are the benefits of a stability study?<\/strong><\/h2>\n\n\n\n

\u2022 confirmation that the declared content of ingredients is maintained<\/p>\n\n\n\n

\u2022 safe shelf life<\/p>\n\n\n\n

\u2022 proof of compliance with the regulatory requirements of the EU and the market where the product is marketed<\/p>\n\n\n\n

\u2022 support for product registration and audits<\/p>\n\n\n\n

\u2022 reduced risk of complaints and financial losses.<\/p>\n\n\n\n

Storage tests are an essential part of quality control of dietary supplements. It allows to determine how long the product remains stable and safe \u2014 both on the European market and in different, more demanding climate zones.<\/p>\n\n\n\n

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 \u2014 tailored to the formulation, product type and target market.<\/p>\n\n\n\n

Contact us!<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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\u2019s 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 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[],"class_list":["post-5270","post","type-post","status-publish","format-standard","hentry","category-vesti-en"],"_links":{"self":[{"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/posts\/5270","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/comments?post=5270"}],"version-history":[{"count":1,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/posts\/5270\/revisions"}],"predecessor-version":[{"id":5275,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/posts\/5270\/revisions\/5275"}],"wp:attachment":[{"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/media?parent=5270"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/categories?post=5270"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/splaboratorija.rs\/en\/wp-json\/wp\/v2\/tags?post=5270"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}