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🔬 Comprehensive Stability Testing at Emery Pharma | Ensuring Drug Quality & Compliance

Welcome to Emery Pharma! In this video, we dive into the critical role of stability testing in pharmaceutical and biologic development. Stability studies are essential for ensuring the quality, potency, and safety of drugs throughout their lifecycle. At Emery Pharma, we offer ICH-compliant stability testing solutions to support regulatory approval and market readiness.

Why Stability Testing Matters
Stability testing is a key component in drug development, ensuring that pharmaceutical and biologic products remain safe and effective under different storage conditions. Our testing helps:
✔️ Identify formulation weaknesses early in development.
✔️ Ensure product efficacy & safety over time.
✔️ Generate regulatory-ready data for FDA, EMA, and global approvals.

ICH-Compliant Stability Studies
We conduct stability studies across all ICH stability zones, ensuring compliance with regulatory guidelines worldwide:
📌 Zone I – Temperate climates (20°C, 45% RH) – U.S., Canada, Northern Europe
📌 Zone II – Subtropical climates (25°C, 60% RH) – Southern Europe, parts of the U.S.
📌 Zone III – Hot & dry climates (30°C, 35% RH) – Middle East, Australia
📌 Zone IVa – Hot & humid climates (30°C, 65% RH) – Brazil, India
📌 Zone IVb – Very hot & humid climates (30°C, 75% RH) – Southeast Asia, Central Africa

Our studies ensure that your pharmaceutical products meet the stability requirements for global market approvals.

Types of Stability Studies at Emery Pharma
We offer a full range of stability testing services designed to meet industry standards:
✅ Real-Time Stability Testing – Long-term monitoring under standard storage conditions.
✅ Accelerated Stability Testing – Simulating fast-tracked aging under extreme conditions.
✅ Forced Degradation Studies – Identifying potential impurity formation pathways.
✅ Photostability Testing – Assessing the impact of light exposure on drug formulations.

Advanced Analytical Capabilities
Emery Pharma utilizes cutting-edge instrumentation to deliver precise and reliable stability data:
🧪 Liquid Chromatography (HPLC, UPLC, LC-MS/MS, HR-MS) – Potency & impurity profiling
🧪 Gas Chromatography (GC-FID, GC-MS) – Residual solvent & volatile impurity analysis
🧪 UV-Vis Spectroscopy – Drug release & formulation performance testing
🧪 Ion Chromatography (IC) – Excipient stability & counterion analysis

Why Choose Emery Pharma for Stability Testing?
🔹 Regulatory Expertise – We generate stability data that meets FDA, EMA, ICH, USP, and EP requirements.
🔹 Advanced Technology – Our high-resolution mass spectrometry and validated methods ensure data integrity.
🔹 Reliable Shelf-Life Determination – We help pharmaceutical companies determine accurate expiration dates.
🔹 End-to-End Support – From method validation to final regulatory submission, we ensure seamless stability study execution.

📩 Get in Touch with Us Today!
If you're looking for expert stability testing solutions, Emery Pharma is here to help!
🌐 Visit our website: www.emerypharma.com
📧 Contact us: [email protected]

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About Emery Pharma:
Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.

Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks.

Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR.

For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at:
https://emerypharma.com/