Tag: ICH Stability Studies

SOP for Determining the Stability of Liposomal Formulations

SOP for Determining the Stability of Liposomal Formulations Procedure for Conducting Stability Studies on Liposomal Drug Formulations 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on liposomal drug formulations to evaluate their shelf life, safety, and efficacy under various environmental conditions such as temperature, humidity, and…

Stability Studies SOP

How to Perform Stability Testing for Complex Drug Products

How to Perform Stability Testing for Complex Drug Products Stability Testing Guidelines for Multi-Component Pharmaceuticals Introduction Complex drug products, which may include combination therapies, multi-layer tablets, or drug-device combinations, require specialized stability testing to ensure their safety and efficacy throughout their shelf life. These products often involve multiple active ingredients or sophisticated delivery systems, making…

'How to' - Stability Studies

How to Conduct Stability Studies for Nasal Gels

How to Conduct Stability Studies for Nasal Gels Stability Testing Guidelines for Nasal Gel Formulations Introduction Nasal gels, used for delivering drugs directly through the nasal mucosa, require rigorous stability testing to ensure their safety and efficacy throughout their shelf life. These products are sensitive to environmental factors such as temperature, humidity, and microbial contamination,…

'How to' - Stability Studies

How to Assess the Impact of Humidity on Drug Stability

How to Assess the Impact of Humidity on Drug Stability Stability Testing Guidelines for Humidity-Sensitive Pharmaceuticals Introduction Humidity can have a significant impact on the stability of pharmaceutical products, particularly those that are hygroscopic or moisture-sensitive. Stability studies that assess the impact of humidity are essential to ensure that the product remains effective and safe…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Inhalation Products

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

Stability Studies SOP

How to Perform Stability Studies for Ophthalmic Ointments

How to Perform Stability Studies for Ophthalmic Ointments Stability Testing Guidelines for Ophthalmic Ointments and Gels Introduction Ophthalmic ointments and gels, used for treating eye conditions, require rigorous stability testing to ensure their safety and efficacy throughout their shelf life. These products must remain sterile and maintain their physical and chemical properties to be effective…

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How to Conduct Stability Studies for Intrathecal Drugs

How to Conduct Stability Studies for Intrathecal Drugs Stability Testing Guidelines for Drugs Administered via the Intrathecal Route Introduction Intrathecal drugs, administered directly into the cerebrospinal fluid (CSF), require rigorous stability testing to ensure their safety and efficacy. This route of administration is used for treatments that must bypass the blood-brain barrier, such as certain…

'How to' - Stability Studies

How to Evaluate Stability for Drugs in Multi-Dose Containers

How to Evaluate Stability for Drugs in Multi-Dose Containers Stability Testing Guidelines for Reusable Pharmaceutical Packaging Introduction Multi-dose containers are commonly used for medications that require multiple administrations, such as insulin vials or ophthalmic solutions. Stability studies for drugs in multi-dose containers are essential to ensure that the product remains sterile, effective, and safe throughout…

'How to' - Stability Studies

SOP for Performing Stability Studies for Orally Disintegrating Tablets

SOP for Performing Stability Studies for Orally Disintegrating Tablets Procedure for Conducting Stability Studies on Orally Disintegrating Tablets 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on orally disintegrating tablets (ODTs) to evaluate their shelf life, disintegration time, and storage conditions under various environmental factors such…

Stability Studies SOP

How to Conduct Stability Studies for Hormone Replacement Therapies

How to Conduct Stability Studies for Hormone Replacement Therapies Stability Testing Guidelines for Hormonal Pharmaceuticals Introduction Hormone replacement therapies (HRT), including treatments for menopause, thyroid disorders, and other hormonal deficiencies, require rigorous stability testing to ensure their efficacy and safety throughout their shelf life. These therapies often involve sensitive hormones that can degrade under environmental…

'How to' - Stability Studies