Emery Pharma offers comprehensive pharmaceutical and biopharmaceutical stability testing services to assess product integrity, safety, and efficacy throughout the drug development lifecycle. Our studies are designed to meet both ICH-compliant regulatory standards and customized R&D needs, enabling clients to establish robust shelf-life claims and ensure regulatory success.
From early-phase stability assessments under flexible R&D conditions to fully ICH-compliant long-term and accelerated studies, our analytical chemists leverage advanced chromatographic and spectroscopic techniques, including HPLC, UPLC, LCMS-MS, NMR, HRMS, and GC-MS, to evaluate product stability across diverse formulations and storage environments. Emery Pharma’s stability programs provide critical data for risk-based decision-making, regulatory submissions, and commercial batch release.
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Target Industry
Pharmaceuticals, Biotechnology
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Applicable Standards
ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E; biologics as applicable per ICH Q5C
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Target Product / Molecule Type
Small Molecules, Biologics, Peptides
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Instrumentation & Analytical Platforms
HPLC, UPLC, LCMS-MS, NMR, HRMS, GC-MS
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Turnaround Time
Dependent on design of stability study
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Sample Requirements
Dependent on design of stability study
Custom & ICH-Compliant Stability Studies
We perform stability studies for a variety of use cases including early formulation assessments, candidate prioritization, stress testing insights, preclinical development support, excursion study validation, client-specific protocol support, risk-based stability assessment, special storage condition testing, shelf-life determination, regulatory submission support, storage condition labeling and commercial batch releases.
Custom and R&D Stability Studies
Description
Our Custom and R&D Stability Studies provide flexible stability testing based on established frameworks such as ICH guidelines but tailored to suit exploratory research and development requirements. These studies are ideal for early-phase formulation assessment, stress testing, and candidate prioritization.
Methodology
Using HPLC, UPLC, LCMS-MS, NMR, HRMS, and GC-MS, Emery Pharma conducts R&D stability studies under controlled yet adaptable conditions. Protocols are developed using a risk-based approach, referencing ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C, while allowing tailored excursions and custom parameters as needed for early-stage decision-making.
Deliverables
• Comprehensive stability data reports with trending analysis
• Risk-based protocol design documentation
• Excursion and stress testing summaries
• Recommendations for next-stage stability studies
ICH-Compliant Stability Studies
Description
Our ICH-Compliant Stability Studies provide long-term, intermediate, and accelerated testing under prescribed temperature and humidity conditions. These studies support regulatory submissions, storage labeling, and commercial release for small molecules, biologics, and peptides, including refrigerated and frozen products.
Methodology
Studies are conducted using HPLC, UPLC, LCMS-MS, NMR, HRMS, and GC-MS instrumentation following ICH Q1A(R2)–Q1E and Q5C for biologics. Testing environments are maintained under ICH-defined conditions (e.g., 25°C/60% RH, 30°C/65% RH, and 40°C/75% RH) to evaluate product degradation, potency, and physical characteristics over time.
Deliverables
• Fully compliant ICH stability reports
• Time-point analytical data and chromatograms
• Shelf-life and storage condition recommendations
• Certificates of Analysis (CoA)
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Our Scientists
Dr. Prajita Pandey, Ph.D. is an accomplished analytical chemist and Associate Director of the Chemistry Department at Emery Pharma, where she leads biologics characterization and protein analysis initiatives. She specializes in developing and validating analytical methods for complex biomolecules such as monoclonal antibodies, ADCs, peptides, and proteins using advanced LC-MS and LC-HRMS technologies.
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ICH-Compliant Stability Zones and Conditions
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)
- Zone IVb – 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.
Method Validation per 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.
Stability chambers at various study conditions are available.
Why Choose Emery Pharma for Pharmaceutical Stability Testing
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GLP/GMP Compliance
All stability studies can be performed under GLP/GMP-compliant conditions, ensuring data integrity and reproducibility for regulatory review and commercial release. -
Regulatory Expertise
In collaboration with our client, our scientists design studies aligned with ICH Q1A–Q1E and Q5C guidelines, helping clients meet global submission requirements for FDA, EMA, and other regulatory agencies. -
Breadth of Instrumentation and Methodologies
With an extensive suite of chromatography and mass spectrometry instruments (HPLC, UPLC, LCMS-MS, NMR, HRMS, GC-MS), Emery Pharma provides comprehensive testing coverage for small molecules, biologics, and peptides. -
Rapid Turnaround Times
Tailored R&D protocols and efficient in-house instrumentation enable fast initiation of both exploratory and regulatory stability studies. -
Cross-Industry Experience
Our team supports clients across pharmaceuticals and biotechnology, offering proven stability solutions from discovery through commercial development.
projects delivered on time
average lead time for study initiation
response time to new requests
Frequently Asked Stability Studies Questions
What are pharmaceutical stability studies?
Stability studies evaluate how a drug product or drug substance maintains its functional characteristics over time under various environmental conditions. The results determine shelf life, storage conditions, and expiration dates.