Lyophilized vs Liquid Biologics: Stability Considerations
Biologics can be formulated in two primary ways:
Click to read the full article.
Stability Testing Types
Stress Testing for Autooxidation in API Development
Available from Pharma SOP:
Click to read the full article.
Emerging Trends in Accelerated Stability Testing for Combination Products
Combination products comprise two or more regulated components — drug, device, or biological — that are physically or chemically combined, co-packaged, or otherwise intended for use together. Stability testing must demonstrate that all components remain effective and safe throughout the shelf life.
Click to read the full article.
Role of Nitrogen Flushing in Oxidation Prevention
Available from Pharma SOP:
Click to read the full article.
Regulatory Differences: EMA vs USFDA Long-Term Stability Requirements
Available from Pharma SOP:
Click to read the full article.
Impact of Moisture Sensitivity in Accelerated Stability Testing
Moisture-sensitive APIs and formulations exhibit physical or chemical instability in the presence of elevated relative humidity (RH). Common mechanisms include hydrolysis, deliquescence, aggregation, and microbial growth.
Click to read the full article.
Photostability of Natural Product-Based Formulations
Available from Pharma SOP:
Click to read the full article.
Thermal Shock Studies in Global Supply Chain Management
Available from Pharma SOP:
Click to read the full article.
Analytical Method Sensitivity for Detecting Photodegradation Impurities
Available from Pharma SOP:
Click to read the full article.
Validating UV Exposure Dosage in Light Stability Chambers
Available from Pharma SOP:
Click to read the full article.