Author: digi

Photolytic Product Formation and Risk Assessment

Photolytic Product Formation and Risk Assessment Assessing Photolytic Product Formation and Risk in Pharmaceutical Formulations Photolytic degradation—the breakdown of drug substances or excipients due to exposure to light—is a critical concern in pharmaceutical development. Exposure to UV or visible radiation can lead to the formation of unexpected degradation products, potentially impacting drug safety, efficacy, and…

Photostability and Oxidative Stability Studies, Stability Testing Types

Regulatory Acceptance of Freeze-Thaw Stability Data

Regulatory Acceptance of Freeze-Thaw Stability Data Regulatory Acceptance of Freeze-Thaw Stability Data in Pharmaceutical Submissions Freeze-thaw stability data are a critical component of pharmaceutical stability programs, particularly for temperature-sensitive products such as biologics, injectables, and vaccines. Regulatory agencies across the globe, including the FDA, EMA, and WHO PQ, expect freeze-thaw studies to support storage claims,…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Best Practices for Monitoring Frequency in Long-Term Stability Studies

Best Practices for Monitoring Frequency in Long-Term Stability Studies Optimizing Stability Monitoring Frequency in Long-Term Studies: A Guide for Pharma Professionals Stability testing over the long term is a regulatory requirement for assigning and maintaining a product’s shelf life. A key element of successful stability testing is selecting appropriate monitoring frequencies — the intervals at…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Excipient Compatibility in Light- and Oxidation-Sensitive Formulations

Excipient Compatibility in Light- and Oxidation-Sensitive Formulations Evaluating Excipient Compatibility in Light- and Oxidation-Sensitive Pharmaceutical Formulations Excipients play a vital role in pharmaceutical formulation—affecting solubility, stability, bioavailability, and manufacturability. However, in formulations containing light- or oxidation-sensitive active pharmaceutical ingredients (APIs), excipients can also be a hidden source of instability. They may generate reactive species, catalyze…

Photostability and Oxidative Stability Studies, Stability Testing Types

Outsourcing Stability Testing to Emerging Markets: Opportunities and Compliance

Outsourcing Stability Testing to Emerging Markets: Opportunities and Compliance Strategic Outsourcing of Stability Testing to Emerging Markets: Regulatory and Operational Insights Introduction Pharmaceutical companies are increasingly outsourcing stability testing activities to Contract Research Organizations (CROs) located in emerging markets such as India, Brazil, China, South Africa, and Southeast Asia. These regions offer cost-effective infrastructure, expanding…

Outsourcing Stability Testing to Emerging Markets, Stability Studies in Emerging Markets

Data Compilation and Reporting in Intermediate and Long-Term Stability Studies

Data Compilation and Reporting in Intermediate and Long-Term Stability Studies Effective Data Compilation and Reporting in Intermediate and Long-Term Stability Studies Accurate compilation and reporting of stability data is crucial for regulatory success in pharmaceutical development. Intermediate and long-term stability studies generate extensive datasets across multiple batches, time points, and storage conditions. Regulators expect these…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Selecting Primary Batches for Real-Time Stability Testing

Selecting Primary Batches for Real-Time Stability Testing Guidelines for Selecting Primary Batches in Real-Time Stability Testing Accurate selection of primary batches is the cornerstone of a well-structured real-time stability program. Regulatory authorities such as ICH, FDA, EMA, and WHO mandate that stability studies reflect the manufacturing variability of the product, ensuring that the assigned shelf…

Real-Time and Accelerated Stability Studies, Stability Testing Types

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines

SOP for Conducting Stability Studies for Biologics Following FDA Guidelines Guidelines for Stability Testing of Biologics as per FDA Guidelines 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting stability studies for biological drug substances and products in accordance with the US FDA guidelines. This SOP aims…

Stability Studies SOP

Case Study: Photostability Challenges in Soft Gelatin Capsules

Case Study: Photostability Challenges in Soft Gelatin Capsules Photostability Challenges in Soft Gelatin Capsules: A Formulation Case Study Soft gelatin capsules (softgels) are widely used for oral delivery of lipophilic drugs and supplements due to their ease of administration and effective bioavailability. However, these dosage forms are also among the most vulnerable to photodegradation. Both…

Photostability and Oxidative Stability Studies, Stability Testing Types

Role of Packaging Color and Opacity in Light Protection

Role of Packaging Color and Opacity in Light Protection How Packaging Color and Opacity Enhance Light Protection in Drug Products Photostability is a critical aspect of pharmaceutical product development, particularly for light-sensitive compounds that degrade upon exposure to UV or visible light. An often underestimated factor in controlling photodegradation is the packaging system—specifically, the color…

Photostability and Oxidative Stability Studies, Stability Testing Types