Author: digi

Stress Testing for Autooxidation in API Development

Stress Testing for Autooxidation in API Development Implementing Stress Testing for Autooxidation in API Development: A Practical Guide Autooxidation is a critical degradation pathway that can compromise the stability, efficacy, and safety of active pharmaceutical ingredients (APIs). As part of a comprehensive stability evaluation, stress testing for oxidative degradation provides essential insight into a molecule’s…

Photostability and Oxidative Stability Studies, Stability Testing Types

Lyophilized vs Liquid Biologics: Stability Considerations

Lyophilized vs Liquid Biologics: Stability Considerations Comparing the Stability of Lyophilized and Liquid Biologic Drug Products Biologic drugs are inherently sensitive to environmental factors like temperature, pH, and agitation. Selecting the right dosage form—lyophilized or liquid—has a profound impact on the stability and viability of these high-value therapies. This tutorial offers a comprehensive comparison of…

Stability Testing for Biopharmaceuticals, Stability Testing Types

Designing Freeze-Thaw Studies for Regulatory Filing Compliance

Designing Freeze-Thaw Studies for Regulatory Filing Compliance Designing Freeze-Thaw Studies for Regulatory Filing Compliance in Pharmaceuticals Freeze-thaw studies are a critical element in pharmaceutical stability testing, particularly for temperature-sensitive biologics, vaccines, injectables, and cold-chain products. Regulatory authorities—including the FDA, EMA, and WHO PQ—require robust and scientifically justified freeze-thaw protocols to support stability claims and label…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Overview of Global Regulatory Guidelines for Stability Testing

Overview of Global Regulatory Guidelines for Stability Testing A Complete Overview of Regulatory Guidelines for Pharmaceutical Stability Testing Introduction Stability testing is a cornerstone of pharmaceutical development and regulatory approval. It determines the shelf life and appropriate storage conditions of drug substances and finished products. Regulatory agencies across the world — including the ICH, U.S….

Regulatory Guidelines

Best Practices for Sample Handling During Photostability Testing

Best Practices for Sample Handling During Photostability Testing Best Practices for Sample Handling in Photostability Testing: Ensuring Accuracy and Compliance Photostability testing, governed by ICH Q1B, plays a critical role in assessing the impact of light on pharmaceutical products. However, even the most rigorous analytical methods can yield compromised results if sample handling is flawed….

Photostability and Oxidative Stability Studies, Stability Testing Types

Matrixing Approaches in Long-Term Study Design

Matrixing Approaches in Long-Term Study Design Optimizing Long-Term Stability Studies with Matrixing: A Strategic Approach In pharmaceutical development, long-term stability testing ensures that a drug product maintains its quality, safety, and efficacy throughout its shelf life. However, testing every combination of strength, dosage form, packaging, and batch can be time-consuming, resource-intensive, and costly. Matrixing—endorsed by…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Real-Time Stability Testing for Emerging Markets with Climatic Challenges

Real-Time Stability Testing for Emerging Markets with Climatic Challenges Real-Time Stability Testing for Pharmaceutical Products in Emerging Markets with Climatic Challenges Pharmaceutical companies aiming to market their products in emerging regions—such as South Asia, Sub-Saharan Africa, Latin America, and Southeast Asia—must design stability studies that reflect the extreme climatic conditions prevalent in these markets. Real-time…

Real-Time and Accelerated Stability Studies, Stability Testing Types

SOP for Developing a Stability-Indicating Method in Compliance with ICH Q2(R1)

SOP for Developing a Stability-Indicating Method in Compliance with ICH Q2(R1) Guidelines for Creating Stability-Indicating Methods as per ICH Q2(R1) 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for developing and validating a stability-indicating method for drug substances and drug products in accordance with the ICH Q2(R1) guidelines….

Stability Studies SOP

Interpreting Photostability Chromatograms for Degradation Profiling

Interpreting Photostability Chromatograms for Degradation Profiling How to Interpret Photostability Chromatograms for Effective Degradation Profiling Chromatographic analysis plays a pivotal role in photostability testing, enabling the identification, quantification, and profiling of degradation products formed upon exposure to light. Interpreting photostability chromatograms is critical for assessing the stability of pharmaceutical substances and ensuring compliance with ICH…

Photostability and Oxidative Stability Studies, Stability Testing Types

Validation of Stability Testing Equipment: GMP Strategy for Pharma

Validation of Stability Testing Equipment: GMP Strategy for Pharma GMP Validation of Stability Testing Equipment in the Pharmaceutical Industry Introduction Validation of stability testing equipment is a foundational requirement in Good Manufacturing Practice (GMP)-compliant pharmaceutical operations. Instruments such as stability chambers, cold rooms, incubators, refrigerators, and freezers used in Stability Studies must undergo documented validation…

Equipment and Calibration, Validation of Stability Testing Equipment