Tag: Product Shelf-life

Poor reproducibility in API release profiles over the product’s shelf life.

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Poor reproducibility in API release profiles over the product’s shelf life. Poor reproducibility in API release profiles over the product’s shelf life. Introduction: The reproducibility of Active Pharmaceutical Ingredient (API) release profiles is a critical component in the pharmaceutical industry, particularly for solid oral dosage forms such as capsules. Ensuring consistent drug release over a…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Managing Root Cause Analysis for Failures in Stability Studies

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Managing Root Cause Analysis for Failures in Stability Studies Managing Root Cause Analysis for Failures in Stability Studies Introduction: In the pharmaceutical industry, stability studies are crucial to ensuring that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Failures in stability studies can lead to significant setbacks in drug…

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Solid Dosage form, Tablets

High variability in stability data for oil-filled capsules.

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High variability in stability data for oil-filled capsules. High variability in stability data for oil-filled capsules. Introduction: In the pharmaceutical industry, maintaining the stability of medicinal products is crucial to ensure their safety, efficacy, and quality over their shelf life. Among various dosage forms, oil-filled capsules—encompassing both hard and soft gelatin variants—present unique challenges in…

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Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms