Stability Testing of Special Medical Food Ingredients
In the development of special medical foods, stability testing of ingredients plays a crucial role. With years of industry experience and advanced analytical platforms, Aprofood provides scientific and rigorous stability testing services for special medical food ingredients, ensuring that the product's quality, efficacy, and safety are effectively safeguarded throughout its lifecycle.
Ensuring Safety and Efficacy: The Imperative of Stability Testing for FSMPs
Foods for Special Medical Purposes (FSMPs) are carefully formulated to meet the nutritional needs of vulnerable populations, such as critically ill patients, individuals with metabolic disorders, elderly patients with swallowing difficulties, and infants. Due to their unique physiological conditions, these groups require highly stable and effective ingredients, making stability testing essential for ensuring product safety and efficacy.
Ensures Ongoing Efficacy and Safety
Stability testing ensures key nutrients and bioactive ingredients remain functional and intact throughout the product's lifecycle, confirming safety and effectiveness.Guarantees Nutritional Consistency
Stability testing verifies that the product consistently delivers the precise nutritional content and functionality as labeled, ensuring reliability for consumers.Supports Formula and Packaging Development
Stability data is vital for optimizing formulas, selecting packaging materials, and defining storage conditions to preserve quality during transport and shelf life.Prevents Ingredient Degradation and Contamination
Stability testing identifies risks such as nutrient breakdown, microbial spoilage, or interactions between ingredients, ensuring product stability and safety.Confirms Predictable Product Performance
Stability testing helps ensure the product's sensory characteristics (taste, odor, texture) and nutritional value remain consistent, preventing changes that could affect acceptance and use.
Our Service
Aprofood is dedicated to providing comprehensive stability testing services for special medical food ingredients. Through multi-dimensional analysis methods, we can accurately predict and monitor the performance of various ingredients under different environmental conditions, ensuring that our clients' products meet strict safety and efficacy requirements. Our stability testing services cover a full range of tests, from accelerated tests to long-term storage trials, encompassing chemical, physical, biological, and microbiological stability, providing solid scientific support for the development and production of special medical foods.
Chemical Stability Testing
Chemical stability is the foundation of product efficacy. Aprofood uses advanced technologies to monitor the changes in key components of ingredients and evaluate their degradation pathways.
- Tracking Core Nutrients: We use techniques such as HPLC, UPLC, and GC to regularly and quantitatively monitor the changes in proteins, amino acids, vitamins (especially unstable vitamins such as Vitamin C and B vitamins), polyunsaturated fatty acids (such as DHA, ARA), as well as probiotics, dietary fibers, and other functional components.
- Degradation Product Analysis: In addition to monitoring nutrient content changes, we also focus on the generation of degradation products. For example, we analyze the primary and secondary products of fat oxidation, Maillard reaction intermediates, and vitamin hydrolysis or oxidation products, to comprehensively assess the product's safety.
- Bioactive Component Efficacy Assessment: For functional factors (e.g., antioxidant phytochemicals such as resveratrol and curcumin), we not only measure their content changes but also assess their bioactivity, such as DPPH free radical scavenging ability or ORAC free radical absorption capacity, to confirm that their efficacy is maintained during the shelf life.
Physical Stability Testing
Physical stability affects the appearance, taste, solubility, and dose accuracy of the product. Aprofood ensures uniformity and ease of use throughout the storage process through physical stability testing.
- Appearance and Color Observation: Under controlled lighting conditions, we evaluate clumping, deliquescence, and discoloration in powder-based ingredients, as well as sedimentation, layering, and flocculation in liquid systems.
- Microscopic Structure Analysis: Using techniques like scanning electron microscopy (SEM) and laser particle size analyzers, we observe changes in powder particle morphology, aggregation phenomena, as well as droplet size distribution and zeta potential variations in emulsions to uncover the root causes of macro instability.
- Functional Property Monitoring: We regularly monitor key functional properties, such as protein solubility, viscosity of thickeners, and encapsulation rate and controlled-release characteristics of microcapsules, to ensure that the product retains good solubility and expected gastrointestinal release behavior during its shelf life.
Microbiological Stability Testing
Microbiological stability testing ensures that the product remains hygienically safe throughout its shelf life, particularly for ingredients containing probiotics and prebiotics.
- Challenge Test: We simulate contamination conditions to evaluate the effectiveness of preservatives or low water activity (Aw) in inhibiting pathogenic and spoilage bacteria, ensuring microbiological safety under various environmental conditions.
- Microbial Monitoring During Shelf Life: According to national standards, we regularly test microbial indicators such as total colony count, coliform bacteria, molds, and yeasts to verify packaging integrity and sterilization effectiveness.
- Probiotic and Prebiotic Stability: For ingredients containing active probiotics, Aprofood focuses on the decline kinetics of live bacteria (CFU). We optimize recovery media and counting methods to precisely track the survival rate of strains like Bifidobacterium and Lactobacillus, while also assessing the stability of co-occurring prebiotics, ensuring the effectiveness of the probiotic combinations.
Solution
Aprofood follows international stability research guidelines to provide customers with personalized stability testing solutions. Our solutions help clients identify unstable factors in raw materials, optimize formulas and production processes, and improve the long-term stability of products in practical applications.
| Test Type |
Purpose |
Conditions |
Core Output |
| Accelerated Stability Testing |
Quickly screen for unstable factors in raw materials, predict stability trends, and provide fast feedback. |
Accelerated conditions: 40°C ± 2°C, 75% ± 5% RH. Periods: 0, 1, 2, 3, 6 months. |
If significant degradation occurs, indicates long-term stability risks, requiring immediate improvements. |
| Long-Term Stability Testing |
Confirm the true stability of the product under actual storage conditions and provide data support for establishing shelf life. |
Testing according to storage conditions on the product label (e.g., room temperature, refrigeration). Periods: 0, 3, 6, 9, 12, 18, 24, 36 months. |
Statistical analysis of key indicators (nutrient content, microbiological, sensory, etc.) to develop degradation models and extrapolate shelf life. |
| Impact Factor Testing |
Explore the sensitivity of raw materials to extreme conditions and evaluate their inherent stability characteristics. |
Tests include: High-temperature testing (60°C), high-humidity testing (RH 90%), intense light exposure testing (4500 lux), pH stability. |
Evaluation of the raw material's stability under extreme conditions to assess its robustness. |
Application
Formula and Process Optimization
Through stability testing, Aprofood helps clients identify unstable ingredients, recommend improvements to formulas, and optimize production processes to reduce ingredient degradation and enhance product stability.
Packaging Design
Based on stability data, Aprofood provides scientific evidence for selecting packaging forms to protect products from light, oxygen, humidity, and other environmental factors.
Storage Condition Optimization
Aprofood's stability testing enables the optimization of storage conditions, offering recommendations on ideal storage environments to maintain product quality throughout its lifecycle. This ensures that products remain effective and safe under various handling and storage conditions.
Stability Testing Service Process for Special Medical Food Ingredients
Aprofood offers a comprehensive stability testing service designed to ensure the long-term safety and efficacy of special medical food ingredients. Our process is tailored to meet specific client needs, from the initial evaluation to the final product optimization, providing scientific data that supports every phase of product development and production.
01 Preliminary Evaluation and Test Plan Development
Based on customer needs, Aprofood's expert team will assess product characteristics, develop a customized stability testing plan, and define the testing objectives and specific experimental conditions.02 Accelerated Stability Testing
In accelerated environmental conditions, we conduct rapid screening to predict the product's stability trends and provide quick feedback, supporting subsequent R&D and production.03 Long-Term Stability Testing
Long-term stability testing under actual storage conditions helps assess the true stability of the product and provides data support for establishing scientific shelf life.04 Data Analysis and Reporting
Through detailed analysis of the testing data, Aprofood's team provides clients with comprehensive reports and specific optimization recommendations.05 Product Optimization and Suggestions
Based on the stability testing results, Aprofood offers targeted formula optimization, process improvements, and packaging solutions to ensure the long-term stability of products in the market.
Why Choose Us?
Aprofood's stability testing services provide comprehensive scientific support for the development and production of special medical food ingredients, ensuring product efficacy and safety throughout its lifecycle. With our professional team and advanced technology platforms, we are a leading provider of stability testing services in the industry. For more information about our stability testing solutions or to discuss your specific project needs, feel free to Contact us. Our expert team will be happy to support your product's success.
For Research Use Only.
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