Protheragen-ING Lab understands the critical importance of stability testing to ensure the efficacy, safety, and quality of pharmaceutical products throughout their shelf life. Accelerated studies help to identify potential stability-related problems with pharmaceutical products at an early stage, enabling manufacturers to resolve issues and make necessary adjustments before the product is released to the market. We specialize in providing comprehensive accelerated stability testing services tailored to pharmaceutical products. With our expertise and compliance with the ICH guidelines, we guarantee reliable and accurate results.
What is accelerated stability testing?
Accelerated stability testing is a key component of drug development and is designed to predict the effects of extended storage of a drug product by simulating the effects of extended storage for shorter durations to quickly assess product stability. Pharmaceuticals are exposed to elevated stress conditions, typically higher temperatures and humidity levels.
Accelerated stability studies provide a faster understanding of potential degradation pathways, helping manufacturers make informed decisions about formulation optimization, packaging materials, and potential stability-related issues early in the product development process.
Our drug stability testing services
Protheragen-ING Lab has a team of experienced scientists and state-of-the-art facilities dedicated to accelerated stability testing according to ICH guidelines. Our experts will work with you to develop a customized stability testing solution that fits your product's specific needs. We consider factors such as dosage form, packaging, and storage conditions to design an optimized test plan.
We use state-of-the-art ICH environmental stability chambers that precisely control temperature and humidity conditions. These chambers simulate a variety of storage conditions, allowing us to accelerate the degradation process and obtain accurate stability data.
Our experts use statistical methods to analyze the data obtained and provide comprehensive reports that summarize your product's stability profile. These reports include degradation kinetics, identification of degradation products, and recommendations for storage conditions and shelf life.
Our accelerated stability testing capabilities include:
- Temperature Cycling Studies.
- High Humidity Studies.
- Freeze-Thaw Studies.
- Photo Stability Studies.
- Stress Testing (Forced Degradation Studies).
- Packaging Compatibility Studies.
Why choose our services?
- Expertise: Our team of experienced scientists specializes in accelerated stability studies that comply with ICH guidelines, ensuring the reliability and validity of your data.
- State-of-the-art facilities: Our cutting-edge facilities with advanced instrumentation and monitoring systems simulate a wide range of environmental conditions to ensure accurate and reproducible results.
- Customized study design: We recognize that every drug product is unique. Therefore, we work closely with our clients to develop customized study protocols that address specific product characteristics and regulatory requirements.
- Comprehensive data analysis: Our team of professionals uses advanced analytical techniques to analyze samples at predetermined time points throughout the study, providing comprehensive data interpretation and actionable insights.
- Regulatory compliance: Our strict adherence to regulatory ICH guidelines ensures that your stability data meets the stringent standards required for regulatory submissions.
Contact us today to learn more about our accelerated stability testing services and how we can support your drug development journey.