Protheragen-ING Lab understands the critical importance of stability testing in the pharmaceutical industry. We are committed to helping pharmaceutical companies meet the highest standards of product quality and safety through our ICH real-time stability testing services. The results of real-time stability testing are used to determine the expiration date (shelf life) and storage conditions of pharmaceutical products. This data is critical for regulatory submissions and is important to ensure the quality, safety, and efficacy of the drug product throughout its shelf life.
Real-time stability studies of pharmaceutical products
The primary objective of real-time stability studies is to accurately predict a product's physical, chemical, and microbiological stability over time under conditions that replicate real-world storage scenarios, including temperature, humidity, and light. In real-time stability testing, the product is stored under recommended storage conditions and monitored until it does not meet product specifications. These studies provide insights into long-term stability and degradation kinetics.
Protheragen-ING Lab specializes in real-time stability testing of pharmaceutical products in compliance with ICH requirements. Our team of experienced scientists and technicians are well versed in the latest regulatory requirements and industry best practices. We utilize state-of-the-art facilities and cutting-edge analytical techniques to provide accurate and reliable stability test results.
- During real-time stability testing, samples of the drug product are typically taken at predetermined points in time and subjected to a variety of tests to assess its stability. These tests may include physical observations, chemical assays, dissolution tests, and microbiological analysis.
- The duration of real-time stability testing depends on factors such as the expected shelf life of the product and the recommended storage conditions for the drug product. The ICH guidelines provide suggested minimum time points for conducting stability tests, typically up to 12 or 24 months depending on the drug class.
Key features of our services
Customized Stability Testing Programs
Protheragen-ING Lab can develop a customized stability testing program based on your specific drug product characteristics, regulatory requirements, and market considerations. Our experts will work closely with you to design a comprehensive stability testing program that meets your unique needs.
In addition to real-time stability testing, we offer accelerated stability studies, which provide valuable insights into your product's stability under accelerated conditions. This can help you predict their behavior over a longer period in a relatively short period.
Storage Conditions
We have ICH environment stability chambers with precisely controlled temperature and humidity to simulate a variety of storage conditions, including long-term, intermediate, and accelerated conditions according to ICH guidelines.
Analytical Testing
Our comprehensive stability testing services include a wide range of analytical tests to evaluate the physical, chemical, and microbiological properties of your drug product during its shelf life. We utilize advanced analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and more.
Stability Report Generation
Upon completion of stability testing, we provide detailed stability reports that include comprehensive data analysis and interpretation. These reports can be used to support regulatory submissions, make informed decisions about product shelf life, and ensure compliance with relevant guidelines.
Benefits of our stability testing services
- Ensure compliance with regulatory requirements and ICH guidelines.
- Gain insight into the stability and shelf life of pharmaceutical products.
- Identify potential degradation pathways and formulation issues.
- Support regulatory submissions and product quality documentation.
- Make informed decisions regarding product shelf life and storage conditions.
- Enhance patient safety by ensuring product quality and efficacy.
Contact us today to discuss how we can assist you in ensuring the long-term stability of your pharmaceutical products.