Tag: USP standards

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

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets

May 12, 2025 Admin

Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Troubleshooting Failures in Acid Resistance Testing of Enteric-Coated Tablets Introduction: Enteric-coated tablets are a critical part of modern pharmacology, designed to protect active ingredients from the acidic environment of the stomach and ensure release in the more neutral pH of the intestine. This targeted delivery system…

Solid Dosage form, Tablets

Difficulty in validating air exchange rates in encapsulation areas.

April 24, 2025 Admin

Difficulty in validating air exchange rates in encapsulation areas. Difficulty in validating air exchange rates in encapsulation areas. Introduction: In pharmaceutical manufacturing, particularly in the production of solid oral dosage forms like capsules, maintaining optimal air quality is crucial. The encapsulation area, where hard and soft gelatin capsules are manufactured, demands stringent environmental controls to…

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

Poor reproducibility in dissolution profiles for lipid-based capsules.

April 24, 2025 Admin

Poor reproducibility in dissolution profiles for lipid-based capsules. Poor reproducibility in dissolution profiles for lipid-based capsules. Introduction: Lipid-based capsules, encompassing both hard and soft gelatin varieties, are critical in the delivery of poorly water-soluble drugs. These formulations improve bioavailability, allowing for efficient drug release and absorption. However, achieving consistent dissolution profiles in lipid-based capsules poses…

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

Inadequate methods for detecting trace levels of insoluble residues.

April 1, 2025 Admin

Inadequate methods for detecting trace levels of insoluble residues. Inadequate Methods for Detecting Trace Levels of Insoluble Residues Introduction: In the pharmaceutical industry, the integrity and purity of drug products are paramount. Particularly with solid oral dosage forms, such as capsules, ensuring that no insoluble residues remain is critical for both efficacy and patient safety….

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

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets

March 28, 2025 Admin

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Introduction: The pharmaceutical industry is tasked with producing high-quality, consistent, and safe medicines. Among the solid dosage forms, film-coated tablets are highly prevalent due to their ease of administration, stability, and patient compliance. Ensuring uniformity in weight is a…

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

Troubleshooting Punch Wear in High-Speed Compression Machines

March 22, 2025 Admin

Troubleshooting Punch Wear in High-Speed Compression Machines Troubleshooting Punch Wear in High-Speed Compression Machines Introduction: In the fast-paced world of pharmaceutical manufacturing, maintaining the integrity and efficiency of high-speed compression machines is vital. These machines play a crucial role in the production of tablets, a primary solid dosage form used globally. However, one of the…

Solid Dosage form, Tablets

Troubleshooting Air Velocity Failures in Cleanroom HVAC Validation

March 22, 2025 Admin

Troubleshooting Air Velocity Failures in Cleanroom HVAC Validation Troubleshooting Air Velocity Failures in Cleanroom HVAC Validation Introduction: In the pharmaceutical industry, maintaining a cleanroom environment is crucial for ensuring product quality and safety. Cleanrooms are controlled environments where the concentration of airborne particles is regulated to specified limits. The HVAC (Heating, Ventilation, and Air Conditioning)…

Solid Dosage form, Tablets

Ensuring Consistency in Content Uniformity Tests Across Batches

March 19, 2025 Admin

Ensuring Consistency in Content Uniformity Tests Across Batches Ensuring Consistency in Content Uniformity Tests Across Batches Introduction: In the pharmaceutical industry, the consistency of content uniformity tests across batches is pivotal to ensuring the safety and efficacy of solid dosage forms, particularly tablets. Content uniformity is a critical quality attribute that determines whether each tablet…

Solid Dosage form, Tablets

Inadequate methods for validating air flow patterns in manufacturing areas.

March 18, 2025 Admin

Inadequate methods for validating air flow patterns in manufacturing areas. Inadequate Methods for Validating Air Flow Patterns in Manufacturing Areas Introduction: In the pharmaceutical industry, ensuring the proper validation of air flow patterns in manufacturing areas is crucial. These environments, often referred to as cleanrooms, are critical for maintaining product integrity and safety. Air flow…

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