Stability Studies SOP

The purpose of this SOP is to establish procedures for evaluating the stability of drugs used in clinical trials. Stability studies ensure that investigational drugs maintain their safety, potency, and efficacy throughout the trial period under various storage and handling conditions.
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The purpose of this SOP is to outline the procedures for conducting stability studies on hormonal products. Hormonal products are susceptible to degradation due to environmental factors like temperature, light, and humidity. This SOP aims to determine their stability and establish appropriate storage conditions to ensure their safety and efficacy.
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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 factors. Stability studies aim to determine the shelf life and appropriate storage conditions to maintain their efficacy and safety.
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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 phase separation, crystallization, and loss of potency. This SOP outlines the procedures for evaluating these effects.
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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 be evaluated to ensure consistent performance throughout the product’s shelf life.
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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 storage conditions.
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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 for assessing these interactions over time.
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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 physical and chemical stability. The stability testing aims to determine the shelf life, storage conditions, and degradation pathways of these drugs.
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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 specified storage conditions. The stability studies will assess various factors such as temperature, humidity, light exposure, and time to determine the product’s shelf life and storage requirements.
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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, humidity, and light exposure.
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