Tag: Stability testing

SOP for Assessing the Stability of Controlled Substances

SOP for Assessing the Stability of Controlled Substances Guidelines for Stability Testing of Controlled Substances 1) Purpose The purpose of this SOP is to outline the procedures for conducting stability studies on controlled substances. Stability testing ensures that these substances maintain their potency, purity, and safety throughout their shelf life under various storage conditions. 2)…

Stability Studies SOP

Pharmaceutical Packaging: Ensuring Stability, Safety, and Sustainability

Packaging and Container-Closure Systems in Pharmaceutical Stability Introduction Packaging and container-closure systems play a pivotal role in ensuring the stability, safety, and efficacy of pharmaceutical products. The integrity of a pharmaceutical product is highly influenced by the type of packaging used, especially considering the environmental factors that could cause degradation. Whether the product is a…

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SOP for Performing Stability Studies for Antivirals

SOP for Performing Stability Studies for Antivirals Guidelines for Stability Testing of Antiviral Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on antiviral drugs. Stability testing is necessary to ensure that antiviral medications retain their potency, safety, and efficacy throughout their shelf life under various…

Stability Studies SOP

SOP for Conducting Stability Studies for Antibiotics

SOP for Conducting Stability Studies for Antibiotics Guidelines for Stability Testing of Antibiotic Drugs 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on antibiotic drugs. Stability testing is essential to ensure that antibiotics maintain their potency, purity, and efficacy under various storage conditions over their shelf…

Stability Studies SOP

SOP for Assessing the Stability of Drugs Under Stress Conditions

SOP for Assessing the Stability of Drugs Under Stress Conditions Guidelines for Forced Degradation Studies of Drug Products 1) Purpose The purpose of this SOP is to provide guidelines for conducting forced degradation studies to assess the stability of drugs under stress conditions. These studies aim to identify degradation products and determine the intrinsic stability…

Stability Studies SOP

How to Conduct Stability Testing for Protein-Based Pharmaceuticals

How to Conduct Stability Testing for Protein-Based Pharmaceuticals A Comprehensive Guide to Stability Studies for Protein-Based Medications Introduction Protein-based pharmaceuticals, including monoclonal antibodies, enzymes, and therapeutic proteins, are complex and sensitive drugs that require meticulous stability testing. These drugs are prone to degradation, including denaturation, aggregation, and loss of biological activity, which can compromise their…

'How to' - Stability Studies

How to Evaluate the Stability of Nanoparticles in Drug Products

How to Evaluate the Stability of Nanoparticles in Drug Products Stability Testing of Nanoparticles in Drug Products: A Comprehensive Guide Introduction Nanoparticles are increasingly used in drug delivery systems to enhance the bioavailability, targeting, and controlled release of drugs. However, their small size and unique physicochemical properties make them susceptible to various forms of instability,…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Orphan Drugs

SOP for Conducting Stability Studies for Orphan Drugs Guidelines for Stability Testing of Orphan Drugs 1) Purpose The purpose of this SOP is to outline the procedures for conducting stability studies on orphan drugs. Orphan drugs, designed to treat rare diseases, require stability testing to ensure their safety, efficacy, and quality under various storage conditions…

Stability Studies SOP

How to Conduct Stability Studies for Small Molecule Drugs

How to Conduct Stability Studies for Small Molecule Drugs Stability Testing of Small Molecule Drugs: A Comprehensive Guide Introduction Small molecule drugs, which constitute a significant portion of pharmaceutical products, require rigorous stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These drugs are often susceptible to degradation due to environmental…

'How to' - Stability Studies

How to Conduct Stability Studies for Antibody-Drug Conjugates

How to Conduct Stability Studies for Antibody-Drug Conjugates Stability Testing of Antibody-Drug Conjugates: A Comprehensive Guide Introduction Antibody-drug conjugates (ADCs) are complex biopharmaceuticals that combine the targeting ability of monoclonal antibodies with the potent therapeutic effects of cytotoxic drugs. The unique structure of ADCs presents significant challenges in stability testing due to the potential for…

'How to' - Stability Studies