Tag: Drug stability studies,

How to Analyze Stability Samples Using HPLC A Step-by-Step Guide to Analyzing Stability Samples Using HPLC Introduction High-Performance Liquid Chromatography (HPLC) is a widely used analytical technique in pharmaceutical stability testing, providing precise and reliable data on the stability of drug products. HPLC is particularly useful for identifying and quantifying degradation products, assessing potency, and…

Read More “How to Analyze Stability Samples Using HPLC” »

How to Perform Humidity Chamber Studies for Drug Products Conducting Humidity Chamber Studies for Drug Products: A Practical Guide Introduction Humidity is a key factor that can significantly affect the stability of drug products. Conducting humidity chamber studies allows pharmaceutical companies to assess how different levels of humidity impact the stability of a drug product…

Read More “How to Perform Humidity Chamber Studies for Drug Products” »

How to Conduct Photostability Testing of Drug Products Step-by-Step Guide to Photostability Testing of Drug Products Introduction Photostability testing is a vital component of the stability testing process, aimed at understanding how exposure to light affects the stability of drug products. Light exposure can lead to the degradation of active pharmaceutical ingredients (APIs), resulting in…

Read More “How to Conduct Photostability Testing of Drug Products” »

How to Determine the Impact of Temperature on Drug Stability Evaluating Temperature’s Impact on Drug Stability: A Comprehensive Guide Introduction Temperature is one of the most critical factors affecting the stability of drug products. Understanding how temperature impacts a drug’s stability is essential for determining proper storage conditions and shelf life. Temperature fluctuations can accelerate…

Read More “How to Determine the Impact of Temperature on Drug Stability” »

SOP for Conducting Stress Testing of Active Pharmaceutical Ingredients (APIs) Procedure for Stress Testing of Active Pharmaceutical Ingredients (APIs) 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stress testing of Active Pharmaceutical Ingredients (APIs) to determine their intrinsic stability and to identify degradation products. This information is used…

Read More “SOP for Conducting Stress Testing of Active Pharmaceutical Ingredients (APIs)” »

How to Establish Shelf Life Using Stability Data Determining Shelf Life with Stability Data: A Step-by-Step Guide Introduction Establishing the shelf life of drug products is a vital step in the pharmaceutical development process, ensuring that the products remain effective and safe for use over time. Shelf life is determined based on stability data, which…

Read More “How to Establish Shelf Life Using Stability Data” »

How to Perform Real-Time Stability Testing for Drug Substances Step-by-Step Guide to Real-Time Stability Testing of Drug Substances Introduction Real-time stability testing is a fundamental aspect of pharmaceutical development, providing the most accurate representation of a drug substance’s stability under normal storage conditions. This type of testing is essential for determining the shelf life and…

Read More “How to Perform Real-Time Stability Testing for Drug Substances” »