Stability-Indicating Assay: Ensuring Product Integrity Over Time
At Sep Analytical labs, we specialize in Stability-Indicating Assays (SIA) to evaluate the potency and degradation profile of pharmaceutical products under various conditions. This critical analysis ensures your product maintains its efficacy, safety, and regulatory compliance throughout its shelf life.
Why Stability-Indicating Assays Matter
Pharmaceutical products are exposed to various stress conditions, including temperature, humidity, light, and oxidation. Our stability-indicating methods detect even the slightest degradation, providing:
- Accurate Potency Assessment – Confirms that the active ingredient remains within specifications.
- Degradation Profiling – Identifies and quantifies impurities and breakdown products.
- Regulatory Compliance – Meets FDA, ICH, and USP guidelines for product stability.
- Extended Shelf Life Confidence – Helps determine appropriate storage conditions and expiration dates
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Our Advanced Testing Approach
We utilize state-of-the-art analytical techniques, including:
- High-Performance Liquid Chromatography (HPLC) – For precise quantification of active ingredients and degradants.
- Fourier Transform Infrared Spectroscopy (FTIR) – For structural confirmation of degradation products.
- pH Analysis – To assess chemical stability in different formulations.
Partner With Us for Reliable Stability Testing
Our expert team ensures your pharmaceutical products remain safe, effective, and compliant over time. Whether you need method development, validation, or routine stability testing, we deliver accurate, timely results to support your drug development and manufacturing processes.
Contact us today to discuss how our stability-indicating assay services can benefit your products!
