Скачать или смотреть What You Need to Know About Pharmaceutical Stability Testing ?

In this in-depth video, we explore one of the most critical but often overlooked components of drug development: pharmaceutical stability testing. Whether you’re in biotech, pharma, academia, or regulatory affairs, understanding how drug products hold up over time is essential for ensuring patient safety, regulatory compliance, and commercial success.

What is Stability Testing and Why Does it Matter?
Stability testing evaluates how a drug’s quality, identity, strength, and purity are affected by environmental conditions like temperature, humidity, and light. It’s a foundational requirement for determining expiration dates, labeling instructions, storage conditions, and overall product integrity.

We Answer Key Questions Like:
• What are the different types of stability studies (accelerated, long-term, photostability, freeze-thaw)?
• How are cutting-edge analytical tools like LC-MS, GC-MS, HPLC, and NMR used to detect degradation?
• Why do FDA, ICH, and USP regulations mandate strict protocols for all pharmaceutical products?
• What should a pharmaceutical stability protocol include to meet regulatory standards and real-world needs?
• How does stability data help with INDs, generic approvals, manufacturing changes, and emergency use?

Types of Products Covered:
From small molecule drugs to complex biologics, including tablets, capsules, injectables, and creams—virtually every dosage form depends on reliable stability testing to make it to market.

Why Collaboration is Key:
This video also highlights how working with an experienced, science-driven contract research organization can accelerate development, reduce costs, and strengthen regulatory submissions.

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Whether you’re developing a novel biologic or improving an existing formulation, this video will help you understand how stability testing can make or break your product.

Want to learn more?
Emery Pharma is a leader in conducting stability studies on both small molecules and biologics. Contact us at [email protected] or visit emerypharma.com to see how we can support your program.

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/