Stability Studies SOP

SOP for Conducting Stability Studies for Biological Extracts Guidelines for Stability Testing of Biological Extracts 1) Purpose The purpose of this SOP is to provide standardized procedures for conducting stability studies on biological extracts. Biological extracts, including enzymes, hormones, and proteins, may have unique stability challenges due to their complex structure and susceptibility to environmental…

Read More “SOP for Conducting Stability Studies for Biological Extracts” »

SOP for Assessing the Impact of Freezing on Drug Stability Guidelines for Evaluating the Impact of Freezing on Drug Stability 1) Purpose The purpose of this SOP is to provide a standardized approach for assessing the impact of freezing on drug stability. Freezing can affect the physical and chemical properties of a drug product, including…

Read More “SOP for Assessing the Impact of Freezing on Drug Stability” »

SOP for Performing Stability Studies for Modified Release Formulations Guidelines for Stability Testing of Modified Release Formulations 1) Purpose The purpose of this SOP is to provide a standardized approach for conducting stability studies for modified release formulations. These formulations are designed to release the active ingredient over a specific period, and their stability must…

Read More “SOP for Performing Stability Studies for Modified Release Formulations” »

SOP for Conducting Stability Studies for Pediatric Formulations Guidelines for Stability Testing of Pediatric Formulations 1) Purpose The purpose of this SOP is to establish procedures for conducting stability studies for pediatric formulations. Stability studies are essential to ensure that pediatric formulations maintain their safety, efficacy, and quality throughout their intended shelf life under various…

Read More “SOP for Conducting Stability Studies for Pediatric Formulations” »

SOP for Evaluating the Stability of Drug-Excipient Mixtures Guidelines for Stability Evaluation of Drug-Excipient Mixtures 1) Purpose The purpose of this SOP is to provide guidelines for evaluating the stability of drug-excipient mixtures. Drug-excipient interactions can impact the stability, efficacy, and safety of the final pharmaceutical product. This SOP aims to establish a standardized method…

Read More “SOP for Evaluating the Stability of Drug-Excipient Mixtures” »

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…

Read More “SOP for Performing Stability Testing for Amorphous Drug Forms” »

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…

Read More “SOP for Conducting Stability Studies for Vaccine 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,…

Read More “SOP for Evaluating the Stability of Nanoparticles in Drug Products” »

SOP for Conducting Stability Studies for Small Molecule Drugs Procedure for Stability Studies on Small Molecule Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on small molecule drugs to evaluate their shelf life, potency, and safety under various environmental conditions such as temperature, humidity, and…

Read More “SOP for Conducting Stability Studies for Small Molecule Drugs” »

SOP for Performing Stability Studies for Protein-Based Drugs Procedure for Conducting Stability Studies on Protein-Based Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on protein-based drugs to evaluate their shelf life, potency, and safety under various environmental conditions such as temperature, humidity, and light exposure….

Read More “SOP for Performing Stability Studies for Protein-Based Drugs” »