Tag: Stability Protocols for New Drugs

SOP for Performing Stability Testing for Amorphous Drug Forms

SOP for Performing Stability Testing for Amorphous Drug Forms Guidelines for Stability Testing of Amorphous Drug Forms 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability testing of amorphous drug forms. Amorphous drug forms are characterized by their lack of a defined crystalline structure, which may affect their…

Stability Studies SOP

How to Determine Degradation Pathways in Stability Studies

How to Determine Degradation Pathways in Stability Studies Identifying Degradation Pathways in Stability Studies: A Comprehensive Guide Introduction Understanding the degradation pathways of drug products is a critical aspect of stability studies. Identifying how and why a drug product degrades under various conditions helps in developing stability-indicating methods, setting appropriate storage conditions, and ensuring the…

'How to' - Stability Studies

How to Conduct Stability Studies for Biologics

How to Conduct Stability Studies for Biologics A Step-by-Step Guide to Conducting Stability Studies for Biologics Introduction Stability studies for biologics are critical in ensuring that these complex and sensitive products maintain their safety, efficacy, and quality throughout their shelf life. Unlike small molecule drugs, biologics are more prone to degradation due to their complex…

'How to' - Stability Studies

How to Interpret Stability Data for Regulatory Submissions

How to Interpret Stability Data for Regulatory Submissions Interpreting Stability Data for Regulatory Submissions: A Step-by-Step Guide Introduction Interpreting stability data is a crucial step in the pharmaceutical development process, particularly when preparing regulatory submissions. Stability data provides insights into the shelf life, storage conditions, and overall quality of drug products, making it a key…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Vaccine Products

SOP for Conducting Stability Studies for Vaccine Products Guidelines for Stability Studies of Vaccine Products 1) Purpose The purpose of this SOP is to outline the procedures and guidelines for conducting stability studies on vaccine products. These studies are critical to ensuring that vaccines maintain their efficacy, safety, and quality throughout their shelf life under…

Stability Studies SOP

How to Analyze Stability Samples Using HPLC

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…

'How to' - Stability Studies

How to Perform Humidity Chamber Studies for Drug Products

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…

'How to' - Stability Studies

How to Conduct Photostability Testing of 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…

'How to' - Stability Studies

SOP for Evaluating the Stability of Nanoparticles in Drug Products

SOP for Evaluating the Stability of Nanoparticles in Drug Products Procedure for Conducting Stability Studies on Nanoparticle Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on nanoparticle drug products to evaluate their shelf life, efficacy, and safety under various environmental conditions such as temperature,…

Stability Studies SOP

How to Determine the Impact of Temperature on Drug Stability

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…

'How to' - Stability Studies