Tag: WHO Stability Guidelines

SOP for Performing Stability Studies for Highly Potent Drugs

SOP for Performing Stability Studies for Highly Potent Drugs Guidelines for Stability Testing of Highly Potent Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on highly potent drugs. These drugs require special handling and storage conditions due to their high pharmacological activity and sensitivity to…

Stability Studies SOP

How to Conduct Stability Studies for Inhalation Products

How to Conduct Stability Studies for Inhalation Products Stability Testing of Inhalation Products: A Comprehensive Guide Introduction Inhalation products, including metered-dose inhalers (MDIs), dry powder inhalers (DPIs), and nebulizer solutions, deliver drugs directly to the lungs and require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. Conducting stability studies…

'How to' - Stability Studies

How to Perform Stability Studies for Orally Disintegrating Tablets

How to Perform Stability Studies for Orally Disintegrating Tablets Stability Testing of Orally Disintegrating Tablets: A Comprehensive Guide Introduction Orally disintegrating tablets (ODTs) are designed to dissolve rapidly in the mouth without the need for water, providing a convenient dosage form for patients who may have difficulty swallowing traditional tablets. Stability testing for ODTs is…

'How to' - Stability Studies

How to Assess the Stability of Powdered Drugs

How to Assess the Stability of Powdered Drugs Stability Testing of Powdered Drugs: A Comprehensive Guide Introduction Powdered drugs, including dry powders for reconstitution and inhalation powders, require stability testing to ensure their safety, efficacy, and quality throughout their shelf life. The stability of powdered drugs can be influenced by factors such as moisture, temperature,…

'How to' - Stability Studies

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