Tag: ICH Q3C

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets

June 3, 2025 Admin

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Introduction: In the pharmaceutical industry, maintaining the purity and quality of solid dosage forms, particularly enteric tablets, is crucial. Enteric tablets, designed to withstand the acidic environment of the stomach and dissolve in…

Solid Dosage form, Tablets

Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation

April 16, 2025 Admin

Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Troubleshooting Residual Solvent Issues in Film-Coated Tablets During Validation Introduction: The pharmaceutical industry is highly regulated, with stringent guidelines ensuring that products are safe and effective for consumers. Among the numerous challenges faced by manufacturers is the control of residual solvents in film-coated tablets. These solvents,…

Solid Dosage form, Tablets

Managing Residual Solvents in Solvent-Based Coating Applications

March 26, 2025 Admin

Managing Residual Solvents in Solvent-Based Coating Applications Managing Residual Solvents in Solvent-Based Coating Applications Introduction: The use of solvent-based coatings in the pharmaceutical industry plays a crucial role in enhancing the stability, appearance, and functionality of solid dosage forms such as tablets. However, managing residual solvents in these applications is paramount to ensure the safety,…

Solid Dosage form, Tablets

Troubleshooting Residual Solvent Levels in Coated Tablets

March 25, 2025 Admin

Troubleshooting Residual Solvent Levels in Coated Tablets Troubleshooting Residual Solvent Levels in Coated Tablets Introduction: Residual solvents in coated tablets are a significant concern in pharmaceutical manufacturing due to their potential impact on product safety, efficacy, and compliance with regulatory standards. These solvents, often used in the tablet coating process, must be carefully controlled to…

Solid Dosage form, Tablets

Troubleshooting Residual Solvent Issues in Sugar-Coated Tablets

March 12, 2025 Admin

Troubleshooting Residual Solvent Issues in Sugar-Coated Tablets Troubleshooting Residual Solvent Issues in Sugar-Coated Tablets Introduction: The pharmaceutical industry is continuously advancing, with an emphasis on improving the quality and safety of its products. One of the critical areas of focus is the formulation and manufacturing of solid dosage forms, particularly sugar-coated tablets. These tablets are…

Solid Dosage form, Tablets

Addressing Residual Solvent Levels in Coated Tablets During In-Process Control

March 12, 2025 Admin

Addressing Residual Solvent Levels in Coated Tablets During In-Process Control Addressing Residual Solvent Levels in Coated Tablets During In-Process Control Introduction: The pharmaceutical industry is governed by stringent regulations to ensure the safety, efficacy, and quality of products. One critical aspect of manufacturing coated tablets is managing residual solvent levels during in-process control. Residual solvents…

Solid Dosage form, Tablets

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets

March 2, 2025 Admin

Solid Dosage form, Tablets