Tag: USP standards

Addressing Challenges in Friability Testing for High-Speed Compression Tablets

March 17, 2025 Admin

Addressing Challenges in Friability Testing for High-Speed Compression Tablets Addressing Challenges in Friability Testing for High-Speed Compression Tablets Introduction: In the pharmaceutical industry, tablets remain one of the most common dosage forms due to their convenience, stability, and ease of administration. However, ensuring the integrity and quality of tablets, especially those produced at high speed,…

Solid Dosage form, Tablets

Ensuring Consistency in Dissolution Testing for Multi-API Tablets

March 16, 2025 Admin

Ensuring Consistency in Dissolution Testing for Multi-API Tablets Ensuring Consistency in Dissolution Testing for Multi-API Tablets Introduction: Dissolution testing is a critical quality control measure in the pharmaceutical industry, particularly for tablets containing multiple active pharmaceutical ingredients (APIs). Ensuring consistency in dissolution testing is vital as it impacts the tablet’s efficacy, safety, and regulatory compliance….

Solid Dosage form, Tablets

Difficulty in testing for uniformity of multi-particulate capsule formulations.

March 16, 2025 Admin

Difficulty in testing for uniformity of multi-particulate capsule formulations. Difficulty in testing for uniformity of multi-particulate capsule formulations. Introduction: In the pharmaceutical industry, ensuring the uniformity of dosage units is crucial for both efficacy and safety. Multi-particulate capsule formulations are increasingly popular due to their flexibility in delivering a consistent dose of active pharmaceutical ingredients…

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

Problems with ensuring consistent water quality in multi-product facilities.

March 16, 2025 Admin

Problems with ensuring consistent water quality in multi-product facilities. Problems with ensuring consistent water quality in multi-product facilities. Introduction: Water quality is a critical factor in pharmaceutical manufacturing, especially in multi-product facilities that produce a diverse range of products. Consistent water quality ensures not only the efficacy and safety of the products but also compliance…

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

Poor reproducibility in recovery rates for rinse sampling validation.

March 15, 2025 Admin

Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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

Addressing Challenges in Friability Testing for Sugar-Coated Tablets

March 15, 2025 Admin

Addressing Challenges in Friability Testing for Sugar-Coated Tablets Addressing Challenges in Friability Testing for Sugar-Coated Tablets Introduction: In the pharmaceutical industry, ensuring the quality and durability of solid dosage forms like tablets is paramount. Among the various quality control tests, friability testing is crucial as it assesses a tablet’s ability to withstand mechanical stresses during…

Solid Dosage form, Tablets

Troubleshooting Uneven Spray Patterns in Automated Coating Machines

March 14, 2025 Admin

Troubleshooting Uneven Spray Patterns in Automated Coating Machines Troubleshooting Uneven Spray Patterns in Automated Coating Machines Introduction: In pharmaceutical manufacturing, the coating of tablets is a critical process that enhances product stability, controls drug release, and improves patient compliance. Automated coating machines have revolutionized this process, offering precision and efficiency. However, uneven spray patterns in…

Solid Dosage form, Tablets

Resolving Failures in Disintegration Testing for Sustained Release Tablets

March 13, 2025 Admin

Resolving Failures in Disintegration Testing for Sustained Release Tablets Resolving Failures in Disintegration Testing for Sustained Release Tablets Introduction: In the pharmaceutical industry, ensuring the efficacy and safety of solid dosage forms such as tablets is paramount. Sustained release tablets, designed to release a drug at a predetermined rate, present unique challenges in quality control,…

Solid Dosage form, Tablets

Difficulty in validating water quality for multi-product capsule facilities.

March 13, 2025 Admin

Difficulty in validating water quality for multi-product capsule facilities. Difficulty in Validating Water Quality for Multi-Product Capsule Facilities Introduction: In the pharmaceutical industry, water quality is a critical component of manufacturing processes, especially in facilities that produce solid oral dosage forms like capsules. Both hard and soft gelatin capsules require water of a specific quality…

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

Ensuring Robustness in Weight Variation Testing During Validation Processes

March 10, 2025 Admin

Ensuring Robustness in Weight Variation Testing During Validation Processes Ensuring Robustness in Weight Variation Testing During Validation Processes Introduction: In the pharmaceutical industry, ensuring the consistency and quality of products is paramount. Among the critical tests conducted during the validation processes of solid dosage forms, weight variation testing holds significant importance. This test ensures that…

Solid Dosage form, Tablets

Common Dissolution Failures in Immediate Release Tablets

March 9, 2025 Admin

Common Dissolution Failures in Immediate Release Tablets Common Dissolution Failures in Immediate Release Tablets Introduction: Immediate release tablets are a cornerstone of oral pharmaceutical dosage forms, designed to disintegrate and release their active ingredients promptly upon ingestion. The dissolution process plays a critical role in ensuring the therapeutic efficacy and bioavailability of these tablets. However,…

Solid Dosage form, Tablets

Validating Purified Water Systems for Cleaning Validation Protocols

March 8, 2025 Admin

Validating Purified Water Systems for Cleaning Validation Protocols Validating Purified Water Systems for Cleaning Validation Protocols Introduction: In the pharmaceutical industry, ensuring the highest standards of cleanliness and quality is paramount. Purified water systems play a crucial role in maintaining these standards, especially in cleaning validation protocols. These systems are designed to produce water meeting…

Solid Dosage form, Tablets