Tag: Stability testing for biologics

Selecting Representative Batches for Stability Studies Pharmaceutical stability studies are a cornerstone of drug development, ensuring that medications maintain their safety and efficacy over time. The key to obtaining meaningful and reliable stability data lies in the selection of representative batches for testing. In this guide, we’ll explore the critical factors and considerations that go…

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Container Types and Closure Systems: Their Crucial Role in Drug Stability When we think about pharmaceuticals, we often focus on the formulation of the drug itself. However, the container in which a drug is stored and the closure system used can have a profound impact on its stability over time. In this comprehensive guide, we…

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Optimal Storage Conditions for Pharmaceuticals Have you ever wondered why your medications come with specific storage instructions? The answer lies in the delicate balance of maintaining a drug’s potency, safety, and efficacy over time. In this guide, we will explore the crucial role of storage conditions, including temperature, humidity, and light exposure, in preserving the…

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Unveiling the Science of  Stability Studies As someone deeply involved in the world of pharmaceuticals, I often find myself in awe of the complex journey a drug takes from development to your medicine cabinet. One crucial aspect of this journey is ensuring that pharmaceutical products remain safe and effective over their intended shelf-life. This is…

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  List of SOPs for Pharmaceutical Stability Studies Stability Study Protocol Preparation and Approval Outline the process for creating and reviewing stability study protocols. Include requirements for study design, testing conditions, sample size, and duration. Stability Sample Management and Handling Detail procedures for collection, labeling, storage, retrieval, and disposal of stability samples. Considerations for batch…

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List of Stability Tests for Pharmaceutical Dosage Forms Solid Dosage Forms (Tablets, Capsules, Powders) Appearance: Visual inspection for color, shape, and physical integrity. Assay/Potency: Quantitative analysis of the active pharmaceutical ingredient (API) content. Dissolution/Disintegration: Evaluation of the rate of drug release. Hardness/Friability: Mechanical strength assessment of tablets and capsules. Uniformity of Dosage Units: Ensuring consistent…

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List of Equipment for Pharmaceutical Stability Sample Storage   Stability Chambers/Cabinets Specialized temperature and humidity-controlled chambers Simulate different storage conditions Used for long-term and accelerated stability studies Environmental Chambers Simulate a wide range of environmental conditions Include temperature, humidity, and light exposure Assess the impact on product stability Walk-In Stability Rooms Larger rooms for higher…

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