Tag: Stability testing best practices

How to Design Real-Time Stability Studies for APIs

How to Design Real-Time Stability Studies for APIs Step-by-Step Guide to Designing Real-Time Stability Studies for APIs Introduction to Real-Time Stability Studies Real-time stability studies are an essential component of pharmaceutical development, ensuring the long-term stability, safety, and efficacy of Active Pharmaceutical Ingredients (APIs). These studies evaluate how APIs respond to storage conditions over time,…

Stability Studies - API

Addressing Temperature and Humidity Excursions in API Stability Studies

Addressing Temperature and Humidity Excursions in API Stability Studies Effective Strategies to Address Temperature and Humidity Excursions in API Stability Studies Introduction to Temperature and Humidity Excursions Temperature and humidity excursions are deviations from the predefined storage conditions for Active Pharmaceutical Ingredients (APIs). These excursions, often caused by environmental changes or logistical challenges, can adversely…

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Regulatory Guidelines for Stability Testing of APIs in Emerging Markets

Regulatory Guidelines for Stability Testing of APIs in Emerging Markets Understanding Regulatory Guidelines for Stability Testing of APIs in Emerging Markets Introduction to Stability Testing in Emerging Markets The global pharmaceutical industry is expanding rapidly into emerging markets, offering new opportunities for drug manufacturers. However, navigating the regulatory landscape in these regions presents unique challenges,…

Stability Studies - API

Stability Challenges in Multi-Source APIs: Tools and Techniques

Stability Challenges in Multi-Source APIs: Tools and Techniques Overcoming Stability Challenges in Multi-Source APIs with Effective Tools and Techniques Introduction to Multi-Source APIs in Pharma Stability Studies The pharmaceutical industry’s reliance on multi-source APIs (Active Pharmaceutical Ingredients) has grown due to globalization and the need for cost efficiency. Sourcing APIs from multiple manufacturers allows flexibility…

Stability Studies - API

Ensuring Quality and Compliance: A Comprehensive Guide to API Stability Studies

API Stability Studies: Introduction What Are API Stability Studies? API Stability Studies involve the systematic evaluation of an Active Pharmaceutical Ingredient (API) to ensure it retains its quality, potency, and safety under various environmental conditions over time. These studies assess how factors like temperature, humidity, and light impact the stability and shelf life of APIs,…

Stability Studies - API

Guide to Conducting Stability Studies on Pharmaceutical Dosage Forms

Follow these instructions to conduct stability studies effectively on various pharmaceutical dosage forms: General Considerations: For each dosage form: Evaluate appearance, assay, and degradation products. Limit degradation product testing for generic products to compendial requirements. Note: The listed tests are not exhaustive. Not every test needs to be included in the stability protocol. Consider safety…

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Stability Studies for Drugs with Low Solubility

Drugs with low solubility present unique challenges in stability studies due to their limited aqueous solubility, which can affect dissolution, bioavailability, and stability under various storage conditions. Conducting stability studies for such drugs requires careful consideration of formulation strategies, analytical methods, and regulatory requirements to ensure accurate assessment of product stability and shelf life. Key…

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Regulatory requirements for stability studies

Regulatory Requirements for Stability Studies in Different Regions Stability studies are an integral part of the drug development process, ensuring the safety, efficacy, and quality of pharmaceutical products throughout their shelf life. Regulatory agencies in different regions, including the United States, Europe, and other countries, have established guidelines and requirements for conducting stability studies to…

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Stability Studies for Peptides and Proteins

Peptides and proteins are biopharmaceuticals with complex structures and delicate chemical properties. Stability studies for peptides and proteins are crucial for assessing their physical, chemical, and biological stability under various storage conditions. These studies provide valuable insights into the degradation pathways, formulation optimization, and shelf-life determination of peptide and protein-based therapeutics. Key Considerations When conducting…

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Conducting stability studies for complex dosage Forms

Considerations for Stability Studies of Complex Dosage Forms Complex dosage forms, such as extended-release formulations, liposomal formulations, and combination products, present unique challenges in stability studies due to their intricate compositions, varied release mechanisms, and susceptibility to degradation. Conducting stability studies for complex dosage forms requires careful consideration of formulation characteristics, manufacturing processes, and regulatory…

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