Tag: ICH guidelines

Troubleshooting Failures in Stability Testing for Film-Coated Tablets

March 30, 2025 Admin

Troubleshooting Failures in Stability Testing for Film-Coated Tablets Troubleshooting Failures in Stability Testing for Film-Coated Tablets Introduction: Stability testing is a critical component in the lifecycle of any pharmaceutical product, especially for film-coated tablets. These tests ensure that the product maintains its intended efficacy, safety, and quality throughout its shelf life. Stability testing evaluates how…

Solid Dosage form, Tablets

Poor correlation between accelerated and real-time stability results.

March 12, 2025 Admin

Poor correlation between accelerated and real-time stability results. Poor correlation between accelerated and real-time stability results. Introduction: Stability testing is an essential component of the pharmaceutical development process. It ensures that a drug product maintains its intended physical, chemical, microbiological, and therapeutic properties throughout its shelf life. Accelerated stability testing and real-time stability testing are…

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

Problems with standardizing temperature conditions during testing.

March 11, 2025 Admin

Problems with standardizing temperature conditions during testing. Problems with Standardizing Temperature Conditions During Testing Introduction: In the pharmaceutical industry, maintaining consistent and controlled testing environments is crucial for ensuring the quality, efficacy, and safety of drug products. This is particularly true for solid oral dosage forms such as capsules, both hard and soft gelatin, where…

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

Poor reproducibility in stability data across multiple batches.

March 8, 2025 Admin

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…

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

Ensuring Consistent Moisture Control During Stability Testing of Coated Tablets

March 6, 2025 Admin

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…

Solid Dosage form, Tablets

Challenges in ensuring consistent capsule integrity under stressed conditions.

March 4, 2025 Admin

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,…

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

Optimizing Stability Testing Conditions for Hygroscopic Tablets

March 4, 2025 Admin

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…

Solid Dosage form, Tablets

Challenges in determining capsule degradation rates under UV light exposure.

March 4, 2025 Admin

Challenges in determining capsule degradation rates under UV light exposure. Challenges in determining capsule degradation rates under UV light exposure. Introduction: In the pharmaceutical industry, ensuring the stability and efficacy of medications is paramount. Capsules, both hard and soft gelatin, are popular solid oral dosage forms due to their ease of use and patient compliance….

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

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies

March 3, 2025 Admin

Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Troubleshooting Failures in Residual Solvent Analysis for Utility Validation Studies Introduction: In the pharmaceutical industry, ensuring the safety and efficacy of products is paramount. Residual solvent analysis plays a critical role in utility validation studies, which are essential to maintaining the integrity of solid dosage…

Solid Dosage form, Tablets

Addressing Non-Compliance in Stability Testing for Coated Tablets

March 1, 2025 Admin

Addressing Non-Compliance in Stability Testing for Coated Tablets Addressing Non-Compliance in Stability Testing for Coated Tablets Introduction: Stability testing is a critical component in the pharmaceutical industry, ensuring that drugs maintain their efficacy, safety, and quality over time. For coated tablets, this becomes even more crucial due to the additional complexity introduced by the coating…

Solid Dosage form, Tablets