In order to deliver quality and safe products to the customers, the food supplements manufacturers must ensure consistency in their supply, production and quality control processes.
FOOD SUPPLEMENTS TESTING
General quality principles for food supplements require testing at minimum three stages:
- raw material testing
- testing of finished products
- stability testing
STABILITY TESTING OF FOOD SUPPLEMENTS
Stability testing of food supplements is one of the main aspects of the quality assurance process. Stability testing or shelf-life stability testing of food supplements is needed to verify that the food supplement meets product specification and the content of active ingredients during declared shelf-life.
Stability study of food supplements is product-specific and includes:
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- Organoleptic evaluation (appearance, color and odor)
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- Physical analysis (for example: tablet hardness, viscosity, rheology etc.)
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- Chemical analysis (content analysis of active ingredients, degradation products etc.)
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- Microbiological testing (according to the industry guidelines for food supplements testing)
The most important part of the stability study is the chemical analysis or active ingredient content analysis, as the manufacturer must ensure a quality product that contains all of the specified active ingredients in adequate quantities by the expiration date.
STABILITY STUDIES FOR FOOD SUPPLEMENTS
Stability studies for food supplements are generally performed at two storage conditions:
1. Real-time stability study – samples are stored simulating the expected storage conditions and use of the products until the expected expiration date specified by the manufacturer.
2. Accelerated stability study – samples are stored in stability chambers at controlled conditions (temperature and humidity) to stimulate the rate of the chemical reactions. The results are used to predict the expiry date over short time period (accelerated studies usually last 6 months). However, the results have to be confirmed with the results of the long-term stability study.
Stability testing of the food supplements is needed to collect suitable data to support the predicted shelf life and storage conditions of the product by the manufacturer.
PRODUCT SPECIFICATION
Stability studies for food supplements are product specific by taking into account various factors including both inherent properties of the formulation and external factors:
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- product dosage form
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- presence of multiple active compounds at various concentration with different stability profiles that may interact with each other
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- presence of metallic ions
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- water activity
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- pH of the product
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- oxidizing or reducing agents
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- environmental factors (temperature, moisture) etc.
COMPLEX FORMULATION
Stability testing is especially important for complex, multivitamin, multi-mineral or products containing various plant extracts. In such products there is a higher possibility for occurrence of various reactions between the components that can results in product destabilization. Therefore, it is important for manufacturers to perform stability testing of the active ingredients to ensure declared content until the stated expiry date.
Manufacturers should invest in quality control and provide references to support product specification and claims since customers are expecting high-quality, effective and safe products that will satisfy their supplements needs.
OUR EXPERTISE
INSLAB experts can help you with design and performance of the stability studies specifically for your products. We follow the industry guidelines and standard operating procedures using state of the art analytical methods to provide you data in support of the quality of your products.
If you need testing of raw materials, vitamins, plant extracts, finished products or stability testing do not hesitate to Contact us and receive your informational quote.