Stability Testing and Sample Storage

Excipients are inactive substances used in pharmaceutical formulations. They serve various functions, such as aiding in the drug’s delivery, enhancing its chemical stability, safety or effectiveness of the pharmaceutical product. Although they are not active ingredients, excipients can influence the stability of the finished product. Synergy Health Utrecht examines the interaction between the API and excipients during stability testing. This helps in understanding how excipients affect the overall stability of the formulation. Ensuring that excipients do not compromise the API’s integrity is essential for maintaining overall quality and patient safety.

Finished formulations are the final products ready for use by patients. Stability testing of these formulations is critical. It ensures that the product remains safe and effective throughout its intended shelf life. Synergy Health Utrecht tests finished formulations under various environmental conditions. This includes factors such as temperature, humidity, and light exposure. The goal is to identify any potential degradation or changes in the product over time. By conducting stability testing, one can establish appropriate storage conditions, determine expiration dates, ensure regulatory compliance and ensuring that patients receive a consistent and effective medication..

Compendial methods are standardized analytical procedures used to test pharmaceutical products. These methods are published in pharmacopeias such as the British (BP), European (EP), Japanese (JP), and United States (USP) Pharmacopeias. Synergy Health Utrecht uses these methods in stability testing to ensure compliance with regulatory standards. Compendial methods provide a reliable framework for testing the stability of pharmaceutical products and a benchmark for regulatory compliance. They cover a wide range of tests, including those for potency, purity, and physical characteristics like dissolution. Compendial methods ensure that the testing is consistent and meets international standards.

Synergy Health Utrecht provides an advanced storage facility specifically designed for pharmaceutical products, ensuring optimal conditions for sample preservation. These storage conditions maintain controlled temperature and humidity levels to cater to the diverse requirements of various products. Proper storage is crucial for safeguarding the integrity of both active pharmaceutical ingredients (APIs) and finished formulations, especially since stability studies often necessitate long-term sample storage. By offering dependable storage solutions, Synergy Health Utrecht ensures that samples remain stable and readily available for testing whenever needed.

Ensuring the quality of pharmaceuticals hinges on rigorous stability testing and effective storage solutions. At Synergy Health Utrecht, we offer a comprehensive suite of services that encompass every aspect of this critical process. From assessing the stability of active pharmaceutical ingredients (APIs) and excipients to evaluating finished formulations, our approach is thorough and meticulous. Utilizing both compendial and tailored methods guarantees that our results are accurate and reliable. Additionally, our state-of-the-art storage facilities are designed to maintain the integrity of pharmaceutical products. Synergy Health Utrecht is dedicated to upholding the safety and efficacy of pharmaceuticals through rigorous stability testing and optimal sample storage solutions.