Author: digi

Chromatographic and Spectrometric Techniques in Stability Testing

Chromatographic and Spectrometric Techniques in Stability Testing Role of HPLC, GC, and Mass Spectrometry in Pharmaceutical Stability Testing Introduction Stability testing in pharmaceuticals demands analytical techniques that are highly sensitive, selective, and reproducible to monitor even the slightest changes in drug composition over time. Among the most critical tools used in this field are High-Performance…

Analytical Techniques in Stability Studies, HPLC, GC, and Mass Spectrometry in Stability Testing

Stability Monitoring Frequency Over 36-Month Study Period

Stability Monitoring Frequency Over 36-Month Study Period Designing a Stability Monitoring Schedule Across 36 Months: Frequency Guidelines and Regulatory Best Practices A robust pharmaceutical stability program doesn’t just hinge on the conditions of testing—it also relies heavily on the timing of sample pull points. Regulatory agencies including the FDA, EMA, and WHO expect structured, risk-based…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Leveraging Accelerated Stability Studies for Rapid Formulation Screening

Leveraging Accelerated Stability Studies for Rapid Formulation Screening How to Leverage Accelerated Stability Studies for Rapid Formulation Screening Accelerated stability testing, traditionally seen as a regulatory requirement for shelf-life estimation, is now an essential tool in early formulation development. By applying stress conditions to formulations during the preclinical or early clinical phases, pharmaceutical developers can…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Validating UV Exposure Dosage in Light Stability Chambers

Validating UV Exposure Dosage in Light Stability Chambers Validating UV Exposure Dosage in Light Stability Chambers: A Step-by-Step Guide for Pharmaceutical Photostability Testing Photostability studies, as mandated by ICH Q1B, require controlled exposure to UV and visible light to assess the stability of pharmaceutical substances and products. A cornerstone of such studies is the accurate…

Photostability and Oxidative Stability Studies, Stability Testing Types

Analytical Method Sensitivity for Detecting Photodegradation Impurities

Analytical Method Sensitivity for Detecting Photodegradation Impurities Ensuring Analytical Method Sensitivity for Detecting Photodegradation Impurities Photostability testing, governed by ICH Q1B, evaluates the impact of light exposure on drug substances and products. A key component of such studies is the ability to detect and quantify photodegradation impurities—often present at low concentrations. Ensuring sufficient analytical method…

Photostability and Oxidative Stability Studies, Stability Testing Types

Thermal Shock Studies in Global Supply Chain Management

Thermal Shock Studies in Global Supply Chain Management Thermal Shock Studies in Global Supply Chain Management: Ensuring Pharmaceutical Stability As pharmaceutical products increasingly travel through complex global supply chains, they are exposed to abrupt and extreme temperature transitions. Thermal shock—sudden changes in temperature from cold to hot or vice versa—poses a significant threat to drug…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Insights and Innovations in Pharmaceutical Stability Studies

Insights and Innovations

Photostability of Natural Product-Based Formulations

Photostability of Natural Product-Based Formulations Photostability Testing of Natural Product-Based Formulations: Strategies for Protecting Herbal Pharmaceuticals Natural product-based pharmaceutical formulations—derived from plant extracts, essential oils, or fermentation products—are gaining popularity for their therapeutic potential. However, these complex formulations are often more sensitive to environmental stressors, particularly light exposure, than their synthetic counterparts. Photostability testing is…

Photostability and Oxidative Stability Studies, Stability Testing Types

Impact of Moisture Sensitivity in Accelerated Stability Testing

Impact of Moisture Sensitivity in Accelerated Stability Testing Understanding the Impact of Moisture Sensitivity in Accelerated Stability Testing Moisture is one of the most influential environmental factors affecting pharmaceutical product stability. When conducting accelerated stability testing, moisture-sensitive drugs and formulations are at increased risk of degradation, leading to erroneous shelf-life projections and regulatory concerns. This…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Regulatory Differences: EMA vs USFDA Long-Term Stability Requirements

Regulatory Differences: EMA vs USFDA Long-Term Stability Requirements EMA vs USFDA: Key Differences in Long-Term Stability Testing Requirements Long-term stability testing is an essential component of pharmaceutical development and lifecycle management. While both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) operate under the principles of ICH Q1A(R2), their…

Intermediate and Long-Term Stability Testing, Stability Testing Types