Tag: Stability testing

Poor reproducibility in stability data across multiple batches.

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Poor reproducibility in stability data across multiple batches. Poor Reproducibility in Stability Data Across Multiple Batches Introduction: In the realm of pharmaceutical manufacturing, ensuring the stability of products is paramount. Stability data are crucial for determining the shelf life and storage conditions of pharmaceutical products, ensuring they remain safe and effective for patients throughout their…

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

Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity

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Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Troubleshooting Moisture Loss in Coated Tablets Stored at Low Humidity Introduction: In the pharmaceutical industry, maintaining the stability and efficacy of drug products is paramount. Coated tablets, a common solid dosage form, are often designed with specific moisture content to ensure their integrity and therapeutic…

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Solid Dosage form, Tablets

Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets

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Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets Introduction: The pharmaceutical industry is driven by the need for quality and consistency, especially when it comes to drug delivery forms like coated tablets. Stability testing is a critical component in ensuring that these tablets…

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Solid Dosage form, Tablets

Addressing API Migration in Bilayer Tablets During Long-Term Testing

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Addressing API Migration in Bilayer Tablets During Long-Term Testing Addressing API Migration in Bilayer Tablets During Long-Term Testing Introduction: Bilayer tablets are an innovative pharmaceutical dosage form designed to deliver two different active pharmaceutical ingredients (APIs) or to control the release of a single API over time. However, the process of ensuring the stability and…

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Solid Dosage form, Tablets

Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability

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Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability Ensuring Adequate Desiccant Placement in Tablet Packaging for Stability Introduction: In the pharmaceutical industry, maintaining the stability of tablet formulations is paramount to ensure efficacy, safety, and shelf life. Tablets are susceptible to degradation from environmental factors such as humidity and temperature, making the role of…

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Solid Dosage form, Tablets

Challenges in ensuring consistent capsule integrity under stressed conditions.

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Challenges in ensuring consistent capsule integrity under stressed conditions. Challenges in ensuring consistent capsule integrity under stressed conditions. Introduction: Capsules, both hard and soft gelatin, are among the most popular solid oral dosage forms in the pharmaceutical industry due to their ease of administration and ability to encapsulate a wide range of medicinal compounds. However,…

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

Optimizing Stability Testing Conditions for Hygroscopic Tablets

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Optimizing Stability Testing Conditions for Hygroscopic Tablets Optimizing Stability Testing Conditions for Hygroscopic Tablets Introduction: Hygroscopic tablets, known for their moisture-absorbing properties, pose unique challenges in the realm of pharmaceutical product stability. Stability testing is a crucial component in the lifecycle of drug development, ensuring that a product maintains its integrity, efficacy, and safety throughout…

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Solid Dosage form, Tablets

Inadequate validation protocols for new capsule formulations.

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Inadequate validation protocols for new capsule formulations. Inadequate Validation Protocols for New Capsule Formulations Introduction: The pharmaceutical industry is continually evolving, with innovations leading to new and effective drug delivery systems. Among these, capsules remain a popular choice due to their ease of administration and ability to encapsulate a wide range of drug compounds. However,…

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

Resolving Failures in Stability Testing Due to Packaging Interaction

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Resolving Failures in Stability Testing Due to Packaging Interaction Resolving Failures in Stability Testing Due to Packaging Interaction Introduction: In the pharmaceutical industry, stability testing is crucial to ensure that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Stability testing evaluates how environmental factors such as temperature, humidity, and…

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Solid Dosage form, Tablets

Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions

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Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Resolving Weight Variations in Tablets Stored in Variable Humidity Conditions Introduction: In the pharmaceutical industry, ensuring the consistency and quality of tablets is paramount. One of the critical quality attributes is tablet weight, which can be significantly affected by environmental conditions, particularly humidity. Weight variations…

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Solid Dosage form, Tablets

Inadequate systems for monitoring gelatin cross-linking during validation.

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Inadequate systems for monitoring gelatin cross-linking during validation. Inadequate systems for monitoring gelatin cross-linking during validation. Introduction: Gelatin capsules, both hard and soft gelatin, are widely used in the pharmaceutical industry due to their versatility and patient compliance benefits. However, one of the key challenges faced during the formulation and manufacturing of gelatin capsules is…

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

Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing

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Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Introduction: In the pharmaceutical industry, the aesthetic and functional integrity of sugar-coated tablets is paramount. The coating not only enhances the appearance but also affects consumer perception and compliance. However, during accelerated stability testing, a crucial phase…

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Solid Dosage form, Tablets