Tag: Analytical Testing

Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets

May 31, 2025 Admin

Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets Managing Calibration Failures in Dissolution Testing Equipment for Coated Tablets Introduction: Dissolution testing is a critical quality control measure in the pharmaceutical industry, especially for coated tablets. It ensures that the drug releases its active ingredients at the intended rate and extent. However, calibration failures…

Solid Dosage form, Tablets

Troubleshooting Non-Conformance in Dissolution Testing Protocols

May 26, 2025 Admin

Troubleshooting Non-Conformance in Dissolution Testing Protocols Troubleshooting Non-Conformance in Dissolution Testing Protocols Introduction: Dissolution testing plays a crucial role in the pharmaceutical industry, ensuring that solid dosage forms like tablets release their active ingredients at the desired rate. When these protocols encounter non-conformance, it can lead to significant setbacks in drug development and manufacturing. Understanding…

Solid Dosage form, Tablets

Ensuring Robustness in Disintegration Time During Validation Testing

May 24, 2025 Admin

Ensuring Robustness in Disintegration Time During Validation Testing Ensuring Robustness in Disintegration Time During Validation Testing Introduction: In the pharmaceutical industry, the disintegration time of tablets is a critical quality attribute that directly impacts drug release and bioavailability. Ensuring robustness in disintegration time during validation testing is essential to maintain consistency in therapeutic efficacy and…

Solid Dosage form, Tablets

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets

May 19, 2025 Admin

Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Root Cause Analysis for Failures in Dissolution Testing for Enteric Tablets Introduction: The pharmaceutical industry is committed to ensuring that medications are safe, effective, and of the highest quality. One critical aspect of this commitment is dissolution testing, particularly for enteric-coated tablets. These tablets…

Solid Dosage form, Tablets

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions.

May 3, 2025 Admin

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Introduction: Dissolution testing is a critical quality control procedure in the pharmaceutical industry, especially for solid oral dosage forms such as capsules. It ensures that the drug releases at the intended…

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

Poor reproducibility in cleaning validation results for multi-product facilities.

April 26, 2025 Admin

Poor reproducibility in cleaning validation results for multi-product facilities. Poor reproducibility in cleaning validation results for multi-product facilities. Introduction: In the pharmaceutical industry, ensuring that equipment is properly cleaned between different product batches is critical to maintaining product quality and patient safety. Multi-product facilities, which manufacture a variety of pharmaceutical products, face unique challenges in…

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

Problems with validating capsule release testing equipment.

April 19, 2025 Admin

Problems with validating capsule release testing equipment. Problems with Validating Capsule Release Testing Equipment Introduction: In the pharmaceutical industry, ensuring the consistent and reliable release of active pharmaceutical ingredients (APIs) from capsules is crucial for therapeutic efficacy. Capsule release testing, also known as dissolution testing, is a critical quality control process used to evaluate the…

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

Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment

April 12, 2025 Admin

Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment Troubleshooting Failures in Cleaning Validation for Multi-Layer Tablet Equipment Introduction: In the pharmaceutical industry, maintaining the cleanliness of equipment is crucial for ensuring product safety and efficacy. Cleaning validation is a critical aspect of Good Manufacturing Practices (GMP) that ensures that equipment used in the production…

Solid Dosage form, Tablets

Difficulty in testing capsules with multi-phase drug release profiles.

April 5, 2025 Admin

Difficulty in testing capsules with multi-phase drug release profiles. Difficulty in testing capsules with multi-phase drug release profiles. Introduction: In the ever-evolving landscape of pharmaceutical development, capsules with multi-phase drug release profiles have emerged as a sophisticated solution to optimize therapeutic outcomes. These formulations are designed to release active ingredients at different intervals, ensuring prolonged…

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

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies

April 3, 2025 Admin

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Introduction: Stability studies are a crucial component of the pharmaceutical development process, ensuring that drug products maintain their intended quality, safety, and efficacy throughout their shelf life. Non-adherence to stability protocols can lead to significant issues, including…

Solid Dosage form, Tablets

Troubleshooting Variability in Thickness Testing for Film-Coated Tablets

March 31, 2025 Admin

Troubleshooting Variability in Thickness Testing for Film-Coated Tablets Troubleshooting Variability in Thickness Testing for Film-Coated Tablets Introduction: In the pharmaceutical industry, the production of film-coated tablets is a critical process that requires meticulous quality control. Thickness testing of these tablets is vital as it ensures uniformity, stability, and efficacy of the dosage form. Variability in…

Solid Dosage form, Tablets

Root Cause Analysis of Failures in Weight Uniformity Tests

March 26, 2025 Admin

Root Cause Analysis of Failures in Weight Uniformity Tests Root Cause Analysis of Failures in Weight Uniformity Tests Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency and quality of dosage forms is paramount. One of the critical quality control tests for solid dosage forms, specifically tablets, is the weight uniformity test. This test…

Solid Dosage form, Tablets