Author: digi

Regulatory Validation of Stability-Indicating Methods in Pharmaceuticals

Regulatory Validation of Stability-Indicating Methods in Pharmaceuticals How to Validate Stability-Indicating Methods for Regulatory Approval Introduction Stability-indicating methods (SIMs) are essential analytical tools used to monitor the potency and purity of pharmaceutical products throughout their shelf life. These methods must not only quantify the active pharmaceutical ingredient (API) but also accurately detect and resolve any…

Analytical Techniques in Stability Studies, Regulatory Validation of Stability-Indicating Methods

Risk Mitigation Strategies for Cold Chain Excursion in Injectables

Risk Mitigation Strategies for Cold Chain Excursion in Injectables Risk Mitigation Strategies for Cold Chain Excursion in Injectable Pharmaceuticals Cold chain excursions—temporary deviations from the required refrigerated storage conditions—pose a significant threat to the stability, efficacy, and safety of injectable pharmaceutical products. From vaccines and biologics to small-molecule injectables, temperature-sensitive formulations must be protected throughout…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Match Stability Study Container-Closure Systems to Final Market Packaging

Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life. If the container-closure system used during testing doesn’t match the one used in the market, the results may not reflect real-world conditions. Packaging directly impacts exposure to moisture, oxygen, and light—all of which influence chemical…

Stability Study Tips

Product-Specific Stability Profiles: A Long-Term Perspective

Product-Specific Stability Profiles: A Long-Term Perspective Building Product-Specific Stability Profiles: A Long-Term Strategic Perspective Pharmaceutical stability studies are not one-size-fits-all. While ICH guidelines offer standardized conditions for long-term testing, the reality is that each product has unique degradation mechanisms, formulation sensitivities, and packaging interactions. Developing a product-specific stability profile allows manufacturers to tailor long-term strategies…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Strategies for Handling and Storing Stability Data for Regulatory Submissions

Strategies for Handling and Storing Stability Data for Regulatory Submissions Compliant Management of Stability Data for Global Regulatory Filing Introduction Stability Studies play a critical role in defining the shelf life, storage conditions, and packaging configuration of pharmaceutical products. The data generated from these studies forms a cornerstone of regulatory submissions worldwide, appearing in technical…

Handling and Storing Stability Data for Regulatory Submissions, Stability Data and Report Management

Oxidative Degradation in Biopharmaceuticals: Risks and Mitigation

Oxidative Degradation in Biopharmaceuticals: Risks and Mitigation Managing Oxidative Degradation in Biopharmaceuticals: Risks and Mitigation Strategies Oxidative degradation is a prevalent and critical degradation pathway affecting the stability, efficacy, and safety of biopharmaceuticals. Proteins and peptides, due to their structural complexity and reactive amino acids, are particularly vulnerable to oxidation. Factors such as exposure to…

Stability Testing for Biopharmaceuticals, Stability Testing Types

Use of Chemical Indicators in Light Exposure Validation

Use of Chemical Indicators in Light Exposure Validation How Chemical Indicators Help Verify Light Exposure in Photostability Testing Photostability testing, guided by ICH Q1B, requires precise control and validation of light exposure to assess how pharmaceutical products respond to visible and ultraviolet (UV) light. One of the most reliable tools used for this purpose is…

Photostability and Oxidative Stability Studies, Stability Testing Types

Global Regulatory Trends in Real-Time Stability Study Requirements

Global Regulatory Trends in Real-Time Stability Study Requirements Global Trends in Regulatory Requirements for Real-Time Stability Studies Real-time stability testing is an essential part of pharmaceutical product development and global regulatory submission. While the core scientific principles are harmonized under ICH guidelines, each regulatory body imposes region-specific nuances that must be considered for compliant product…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Oxidative Stress Testing of Solid Oral Dosage Forms

Oxidative Stress Testing of Solid Oral Dosage Forms Best Practices for Oxidative Stress Testing in Solid Oral Pharmaceutical Dosage Forms Oxidative degradation is a key concern in the stability of solid oral dosage forms (SODFs) like tablets, capsules, and powders. Even though these forms may appear physically robust, chemical instability due to exposure to oxygen…

Photostability and Oxidative Stability Studies, Stability Testing Types

Pharmaceutical Containers and Closures in Stability Testing

Pharmaceutical Containers and Closures in Stability Testing Pharmaceutical Containers and Closures: Ensuring Stability and Compliance Introduction The choice of containers and closures plays a decisive role in the pharmaceutical product lifecycle, especially in determining stability, shelf life, and patient safety. Packaging components such as bottles, vials, caps, stoppers, and liners must not only be inert…

Packaging and Containers, Pharmaceutical Containers and Closures for Stability