Tag: Analytical Chemistry

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 Calibration Failures in Dissolution Testing Equipment

May 10, 2025 Admin

Troubleshooting Calibration Failures in Dissolution Testing Equipment Troubleshooting Calibration Failures in Dissolution Testing Equipment Introduction: Dissolution testing is a critical process in the pharmaceutical industry, serving as a quality control measure to ensure the efficacy and safety of tablets and other solid dosage forms. Calibration of dissolution testing equipment is essential for accurate and reliable…

Solid Dosage form, Tablets

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets

April 28, 2025 Admin

Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Managing Non-Homogeneity in Dissolution Profiles for Coated Tablets Introduction: Coated tablets are a widely used solid dosage form in the pharmaceutical industry, offering benefits such as improved taste masking, controlled drug release, and enhanced stability. However, achieving consistent dissolution profiles is critical as it directly impacts the…

Solid Dosage form, Tablets

Poor reproducibility in assay testing for encapsulated suspensions.

April 18, 2025 Admin

Poor reproducibility in assay testing for encapsulated suspensions. Poor reproducibility in assay testing for encapsulated suspensions. Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of drug products is paramount. Encapsulated suspensions, particularly in the form of hard and soft gelatin capsules, present unique challenges in maintaining consistent assay results. Assay testing is critical…

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

Poor reproducibility in disintegration testing for coated capsules.

April 15, 2025 Admin

Poor reproducibility in disintegration testing for coated capsules. Poor reproducibility in disintegration testing for coated capsules Introduction: In the pharmaceutical industry, disintegration testing is a critical quality control measure that ensures that oral dosage forms, such as capsules, break down within a specified time to release their active ingredients. This is particularly important for coated…

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

Poor reproducibility in swab recovery rates for potent APIs.

April 15, 2025 Admin

Poor reproducibility in swab recovery rates for potent APIs. Poor reproducibility in swab recovery rates for potent APIs. Introduction: In the pharmaceutical industry, ensuring the cleanliness of manufacturing equipment is critical, especially when dealing with potent active pharmaceutical ingredients (APIs). Swab recovery studies are essential for validating the cleaning processes that remove residues from surfaces….

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

Poor validation of analytical methods for multi-drug capsule formulations.

April 3, 2025 Admin

Poor validation of analytical methods for multi-drug capsule formulations. Poor validation of analytical methods for multi-drug capsule formulations. Introduction: In the pharmaceutical industry, the development of multi-drug capsule formulations is a sophisticated process that requires precision and accuracy. The validation of analytical methods for these formulations is crucial as it ensures the quality, efficacy, and…

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

Investigating Failures in Dissolution Testing for Sustained Release Tablets

March 22, 2025 Admin

Investigating Failures in Dissolution Testing for Sustained Release Tablets Investigating Failures in Dissolution Testing for Sustained Release Tablets Introduction: The pharmaceutical industry is a cornerstone of modern medicine, with sustained release tablets playing a crucial role in controlled drug delivery systems. These formulations are designed to release the active pharmaceutical ingredient (API) at a predetermined…

Solid Dosage form, Tablets

Managing Root Cause Analysis for Failures in Stability Studies

March 22, 2025 Admin

Managing Root Cause Analysis for Failures in Stability Studies Managing Root Cause Analysis for Failures in Stability Studies Introduction: In the pharmaceutical industry, stability studies are crucial to ensuring that a drug product maintains its intended quality, safety, and efficacy throughout its shelf life. Failures in stability studies can lead to significant setbacks in drug…

Solid Dosage form, Tablets

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets

March 20, 2025 Admin

Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Ensuring Robustness in Content Uniformity Tests for Multi-Layer Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of solid dosage forms such as multi-layer tablets is of paramount importance. Multi-layer tablets offer the advantage of combining different drugs or release profiles in a single…

Solid Dosage form, Tablets

Poor reproducibility in monitoring capsule disintegration profiles.

March 6, 2025 Admin

Poor reproducibility in monitoring capsule disintegration profiles. Poor reproducibility in monitoring capsule disintegration profiles. Introduction: The disintegration profile of capsules is a critical quality attribute that significantly impacts the bioavailability and therapeutic efficacy of the drug product. Ensuring consistent and reproducible disintegration times is essential for achieving regulatory compliance and maintaining product quality. Despite its…

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