In the dynamic world of dietary supplements, ensuring the quality and safety of products is paramount. One crucial aspect of this assurance is stability studies.
Neotron, a leading Cotecna Group analytical service provider, recognizes the pivotal role stability studies plays in maintaining the effectiveness and safety of supplements over time.
In this article, we delve into the reasons why stability studies is indispensable, Neotron's monitoring parameters, the choice between long-term and accelerated studies, and how Neotron ensures the stability of organoleptic and physical properties, microbiological parameters, and nutritional compounds.
1. Why is Stability studies Crucial for Supplements?
Stability studies is the scientific process that examines how various environmental factors impact the quality of food supplement products over time. Neotron emphasizes that this testing is essential not only for determining the shelf life and recommended storage conditions but also for ensuring that the expected levels of active ingredients are maintained. It serves as a safeguard against organoleptic changes, microbial contamination, and alterations to packaging integrity. The ultimate goal is to provide consumers with products that are not only potent but also safe and fresh throughout their expected life.
2. What Parameters Does Neotron Monitor in Stability studies?
Neotron meticulously monitors a range of parameters during stability studies to comprehensively evaluate supplement quality over time. These parameters include organoleptic properties, dietary ingredient strengths, chemical fingerprints, microbial growth, preservative content, moisture content, disintegration, dissolution, pH, viscosity, and oxidation. By adhering to guidelines from authorities like NSF and FDA, Neotron ensures that its testing is robust and tailored to each product. This thorough monitoring guarantees that the supplement remains effective and maintains its quality throughout its shelf life.
3. Long-Term vs. Accelerated Stability Testing: When to Choose What?
The decision to opt for long-term or accelerated stability study depends on various factors. Long-term studies simulate recommended storage conditions over an extended period, while accelerated studies provide early indications of potential issues. Neotron assists clients in determining the most suitable approach based on different climate zones, following ICH guidelines. The company performs studies in chambers simulating ICH Stability Zones, offering both long-term and accelerated testing services to ensure a comprehensive evaluation of product stability.
4. Ensuring Organoleptic and Physical Properties: What Does It Entail?
Neotron pays special attention to organoleptic and physical properties during stability studies. Organoleptic characteristics such as odor, color, appearance, and package integrity are assessed to guarantee a positive consumer experience. Physical properties are evaluated through disintegration tests, dissolution tests, hardness tests, and pH measurements. Neotron's commitment to assessing these aspects ensures that supplements not only meet label claims but also provide a satisfactory consumer experience.
5. Microbiological Parameters and Nutritional Compounds: How are They Monitored?
Microbiological analysis and assessment of nutritional compounds are critical components of Neotron's stability studies. Through standardized analyses, the company monitors the possible presence of contaminants and ensures that nutritional compounds remain at expected levels. This comprehensive approach safeguards the end-user against potential health risks and guarantees the nutritional integrity of the supplement.
Stability studies is a cornerstone in the development and quality assurance of dietary supplements. Neotron's commitment to monitoring a diverse range of parameters and adhering to industry guidelines ensures that supplements not only meet regulatory standards but also exceed consumer expectations. Through a robust stability testing process, Neotron contributes to a healthier and more reliable supplement market, ultimately benefiting both manufacturers and end-users alike.