Tag: Shelf Life Testing of Drugs

SOP for Conducting Stability Studies for Ready-to-Use IV Bags

SOP for Conducting Stability Studies for Ready-to-Use IV Bags Guidelines for Stability Testing of Ready-to-Use Intravenous (IV) Bags 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on ready-to-use intravenous (IV) bags. Stability studies are necessary to ensure that the drug solution within the IV bag remains…

Stability Studies SOP

How to Conduct Stability Studies for Biotech Products

How to Conduct Stability Studies for Biotech Products Stability Testing of Biotech Products: A Comprehensive Guide Introduction Biotech products, including biologics, vaccines, and gene therapies, are highly complex and sensitive to environmental factors, making stability testing particularly important. Conducting stability studies for biotech products is crucial to ensure that these products maintain their safety, efficacy,…

'How to' - Stability Studies

How to Perform Stability Studies for Radiopharmaceuticals

How to Perform Stability Studies for Radiopharmaceuticals Stability Testing of Radiopharmaceuticals: A Comprehensive Guide Introduction Radiopharmaceuticals, which are used in both diagnostic imaging and therapy, require specialized stability testing due to their radioactive nature and the potential for rapid decay. Conducting stability studies for radiopharmaceuticals is crucial to ensure that these products maintain their efficacy,…

'How to' - Stability Studies

How to Evaluate Stability in Cold Chain Products

How to Evaluate Stability in Cold Chain Products Stability Testing for Cold Chain Products: A Comprehensive Guide Introduction Cold chain products, such as vaccines, biologics, and certain pharmaceuticals, require strict temperature control during storage and transportation to maintain their stability, efficacy, and safety. Stability testing for cold chain products is critical to ensure that these…

'How to' - Stability Studies

SOP for Assessing the Impact of Storage Conditions on Drug Products

SOP for Assessing the Impact of Storage Conditions on Drug Products Guidelines for Evaluating the Impact of Storage Conditions on Drug Products 1) Purpose The purpose of this SOP is to provide guidelines for assessing the impact of different storage conditions on the stability of drug products. The study aims to evaluate the effects of…

Stability Studies SOP

How to Conduct Stability Studies for Nasal Sprays

How to Conduct Stability Studies for Nasal Sprays Stability Testing of Nasal Sprays: A Comprehensive Guide Introduction Nasal sprays, which deliver drugs directly to the nasal cavity, require rigorous stability testing to ensure their efficacy, safety, and quality throughout their shelf life. Stability studies for nasal sprays are particularly important due to the potential impact…

'How to' - Stability Studies

How to Perform Stability Studies in Line with ICH Guidelines

How to Perform Stability Studies in Line with ICH Guidelines Stability Testing According to ICH Guidelines: A Step-by-Step Guide Introduction The International Council for Harmonisation (ICH) has established globally recognized guidelines for the stability testing of pharmaceuticals. Conducting stability studies in line with ICH guidelines ensures that drug products meet the necessary quality standards for…

'How to' - Stability Studies

How to Assess the Stability of Fixed-Dose Combinations

How to Assess the Stability of Fixed-Dose Combinations Stability Testing of Fixed-Dose Combinations: A Comprehensive Guide Introduction Fixed-dose combinations (FDCs), which contain two or more active pharmaceutical ingredients (APIs) in a single dosage form, present unique challenges in stability testing due to potential interactions between the different components. Conducting stability studies for FDCs is crucial…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Drugs in Pre-Filled Syringes

SOP for Conducting Stability Studies for Drugs in Pre-Filled Syringes Guidelines for Stability Testing of Drugs in Pre-Filled Syringes 1) Purpose The purpose of this SOP is to outline the procedures for conducting stability studies on drugs stored in pre-filled syringes. Stability studies ensure that drugs maintain their safety, potency, and quality throughout their shelf…

Stability Studies SOP

How to Conduct Stability Studies for Transdermal Patches

How to Conduct Stability Studies for Transdermal Patches Stability Testing of Transdermal Patches: A Step-by-Step Guide Introduction Transdermal patches, which deliver drugs through the skin, require rigorous stability testing to ensure their efficacy, safety, and quality throughout their shelf life. The unique nature of transdermal patches, including their adhesive properties and the interaction between the…

'How to' - Stability Studies