Comprehensive Stability Testing and Analytical Expertise
At Emery Pharma, we provide comprehensive stability testing to ensure the quality, potency, and safety of pharmaceutical products, biologics, medical devices, and consumer goods. Stability testing is more than just placing products in controlled environments—it requires precise analytical methods to monitor degradation, impurity formation, and shelf-life.
With our ICH-compliant stability studies and state-of-the-art analytical capabilities, we generate high-quality, regulatory-ready data to support your product development and approval.
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ICH-Compliant Stability Studies
Our team specializes in stability testing designed to meet global regulatory standards. We conduct studies under all ICH stability zones, ensuring compliance for U.S., European, and global markets:
- Zone I – Temperate climates (25 °C ± 2 °C, 60% ± 5% RH)
- Zone II – Subtropical climates (25 °C ± 2 °C, 60% ± 5% RH)
- Zone III – Hot and dry climates (30 °C ± 2 °C, 35% ± 5% RH)
- Zone IVa – Hot and humid climates (30 °C ± 2 °C, 65% ± 5% RH)
- Accelerated Ambient – Very hot and humid climates (30 °C ± 2 °C, 75% ± 5% RH)
Our stability studies include long-term, intermediate, accelerated, and forced degradation testing to provide a complete picture of product stability.
These studies allow us to assess the impact of environmental conditions on product potency, purity, and overall quality.
Contact Us!
Get in touch with our team today for a consultation or quote for your stability study.
Analytical Method Development & Validation (ICH Q2(R2))
Stability testing isn’t just about storing samples—it requires robust, stability-indicating analytical methods to detect even the smallest chemical changes. At Emery Pharma, we validate our methods using ICH Q2(R2) guidelines, ensuring they are:
- Specific – Accurately identifying active ingredients and degradation products
- Precise & Accurate – Delivering reliable, repeatable results
- Sensitive – Capable of detecting trace-level impurities
- Robust – Performing consistently across variable conditions
By simulating real-world conditions, our validation ensures that your product stability data is accurate, defensible, and regulatory-compliant.
Advanced Analytical Capabilities for Stability Testing
To support stability studies, our laboratory is equipped with state-of-the-art instrumentation for precise and reliable analysis:
- Liquid Chromatography (HPLC, UPLC, LC-MS/MS, HR-MS) – Potency testing, impurity profiling, and degradation studies
- Gas Chromatography (GC-FID, GC-MS) – Residual solvents and volatile impurity analysis
- UV-Vis Spectroscopy – Drug release and formulation performance assessment
- Ion Chromatography (IC) – Counterion analysis and excipient stability testing
Our ICH Q1A(R2)-compliant methods meet FDA, EMA, USP, and EP regulatory requirements, ensuring the highest data integrity for regulatory submissions.
