Tag: Stability testing protocols,

FDA and EMA Requirements for Stability Chamber Validation

FDA and EMA Requirements for Stability Chamber Validation Expert Guide to FDA and EMA Stability Chamber Validation Requirements Introduction Stability chamber validation is a critical component of pharmaceutical quality assurance, ensuring that chambers used for stability testing maintain precise environmental conditions. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)…

Regulatory Guidelines

The Relationship Between Shelf Life and Product Potency Over Time

The Relationship Between Shelf Life and Product Potency Over Time Understanding the Link Between Shelf Life and Potency in Pharmaceuticals Introduction: Why Potency Matters in Shelf Life Potency is a critical quality attribute in pharmaceuticals, representing the ability of a drug to produce its intended therapeutic effect. Over time, the potency of a drug can…

Shelf Life and Expiry Dating

Understanding Matrixing and Bracketing in Stability Studies

Understanding Matrixing and Bracketing in Stability Studies A Step-by-Step Guide to Matrixing and Bracketing in Stability Studies Introduction to Matrixing and Bracketing Stability studies are critical for ensuring the quality, safety, and efficacy of pharmaceutical products over time. However, testing every possible combination of product strengths, packaging configurations, and storage conditions can be resource-intensive and…

Types of Stability Studies

Addressing Humidity Sensitivity in Stability Testing for APIs

Addressing Humidity Sensitivity in Stability Testing for APIs Effective Strategies for Addressing Humidity Sensitivity in Stability Testing for APIs Introduction to Humidity Sensitivity in APIs Humidity sensitivity is a significant challenge in the stability testing of Active Pharmaceutical Ingredients (APIs). Exposure to high humidity can lead to chemical degradation, physical instability, and reduced efficacy of…

Stability Studies - API

Shelf Life and Stability Testing for Combination Drug Products

Shelf Life and Stability Testing for Combination Drug Products Exploring Shelf Life and Stability Testing for Combination Drug Products Introduction: The Complexity of Combination Drug Products Combination drug products, which integrate two or more active pharmaceutical ingredients (APIs) into a single formulation, are gaining popularity for their therapeutic advantages. However, their complexity poses unique challenges…

Shelf Life and Expiry Dating

Stability Testing for New Drug Substances: Regulatory Insights

Stability Testing for New Drug Substances: Regulatory Insights Expert Guide to Stability Testing for New Drug Substances Introduction to Stability Testing for New Drug Substances Stability testing is a critical step in the development of new drug substances, ensuring that they remain safe, effective, and high-quality throughout their intended shelf life. For pharmaceutical manufacturers, meeting…

Types of Stability Studies

ICH Stability Storage Conditions: Designing Effective Programs

ICH Stability Storage Conditions: Designing Effective Programs Step-by-Step Guide to Designing Stability Programs with ICH Storage Conditions Introduction Stability testing is a cornerstone of pharmaceutical development, ensuring that products maintain their quality, safety, and efficacy over time. The International Council for Harmonisation (ICH) provides a globally accepted framework for stability testing, including specific storage conditions…

Regulatory Guidelines

Using Big Data to Enhance API Stability Study Outcomes

Using Big Data to Enhance API Stability Study Outcomes Harnessing Big Data to Optimize API Stability Study Outcomes Introduction to Big Data in API Stability Studies The pharmaceutical industry is increasingly leveraging big data to enhance the reliability and efficiency of API stability studies. Stability studies are critical for determining the shelf life, storage conditions,…

Stability Studies - API

How Shelf Life Differs Between Biologics and Small Molecules

How Shelf Life Differs Between Biologics and Small Molecules Understanding the Differences in Shelf Life Between Biologics and Small Molecules Introduction: A Comparison of Biologics and Small Molecules Biologics and small molecules are two primary categories of pharmaceutical products, each with unique characteristics that influence their shelf life. While small molecules are chemically synthesized and…

Shelf Life and Expiry Dating

Key Considerations in Intermediate Stability Studies for Global Markets

Key Considerations in Intermediate Stability Studies for Global Markets Understanding Intermediate Stability Studies for Global Pharmaceutical Markets Introduction to Intermediate Stability Studies Stability testing is a cornerstone of pharmaceutical development, ensuring that drug products maintain their safety, efficacy, and quality over time. Among the various types of stability studies, intermediate stability studies play a unique…

Types of Stability Studies